Help! FDA 2877. How to fill out? Anyone?? Just found out about it. Redsail Laser

[Clark Pace]

I frantically looking for an answer. My x700 unit arrives into port on the 17th of May. By broker which is Delmare told me today that Redsail needs to fill out an FDA for 2877 for the laser to clear customs. I wish I would have known about this way before. I contacted Redsail and they said that I have to fill it out. Here is the link to the form if you wish to see it. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080778.pdf

Anyways. Woh!!! I have no idea what to put in. And I know if I do it wrong I'm for a world of hurt. My first broker at Delmare is out of town and I working with some one else who I suspect has not done one of these before I have done very few of them. My original broker won't be back until after the unit arrives. Anyone here purchased from redsail and had to fill out this form????

Oh yeah I'm in the USA.

[Bruce Dorworth]

I don't believe there is anything YOU can do. This is something that RedSail has to do. It is similar to the UL rated for electronic part. RedSail has to have one of their lasers tested and then they will get a certificate with a number on it. They then send a copy with their lasers.

Bruce

[John Finnegan]

Bruce is absolutely correct - your laser manufacturer must have this on file to import to the US. It is their responsibility.
I've heard stories of the FDA both holding laser shipments and not. I think one of the forum members had their's held for a couple weeks, even while having the appropriate certificate. I'm not sure if there is a reason behind the FDA flagging a laser, or if it is just a random check.

[Walt Langhans]

I think one of the forum members had their's held for a couple weeks,

Yup that was me, and yes Bruce is 100% correct. It's the companies responsibility to make sure that the laser meets all the FDA requirements, and they have to do the paperwork. Don't let them tell you different. BTW it's going to take at least 3-4 weeks even if they have all their ducks in a row.

[Lucy Lee]

@ Clark Pace,
Yes write to redsail ask for FDA, they will know and send a paper with accession number,

Best Regards

[Joe Kaminski]

Hello Clark,
The manufacturer has nothing to do with the importation process once they ship your laser. You (and your broker) have full responsibility. Ultimately you are fully responsible for your import, even if your broker does something wrong. I'm sure they had you sign giving them power of attorney for your import.
FDA 2877 needs to be filled out by you (if you are the importer of record or will be the final user of this laser). Request a copy of the FDA compliance letter from the MANUFACTURER showing the accession number. You will fill this number in on B1 of form 2877. Wait for FDA to contact you requesting info, then respond with this completed, signed form sent to the specific email address that will be provided to you. Follow these simple directions (exactly as the FDA will direct you) and your laser will be released from detention if a few days after receiving your form 2877.
It's really not that hard. You will be uncrating your laser soon.
Good Luck!

[George Carlson]

There's no need for any detention. If Delmar gets the 2877, they can pay the fee and get the FDA release the laser before it reaches the shore. It's customs that will give you the grief. In my case the container had to be x-rayed (time and money), then customs decided my crate needed intense inspection. (more time and even more money). So, do to customs, my crate spent more time at Long Beach than it did on the ship.

[Bruce Dorworth]

Like Lucy said, RedSail HAS to provide the accession number. I am sure that is something that they already have. Anyone that says anything different has not imported a laser in from China in the last 6-12 months.

Good luck,
Bruce

[Clark Pace]

The two things I found that I needed were the acession # and the name of the company on record with the FDA. It has to match exactly. Luckly for me my machine was not flagged and went though without the paper work.