The following data is part of a premarket notification filed by Genicon, Lc with the FDA for Genicon Clip Applier.
| Device ID | K030269 |
| 510k Number | K030269 |
| Device Name: | GENICON CLIP APPLIER |
| Classification | Clip, Implantable |
| Applicant | GENICON, LC P.O. BOX 780038 Orlando, FL 32878 -0038 |
| Contact | Frank Goldfarb |
| Correspondent | Frank Goldfarb GENICON, LC P.O. BOX 780038 Orlando, FL 32878 -0038 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-27 |
| Decision Date | 2003-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877972006343 | K030269 | 000 |