The following data is part of a premarket notification filed by Genicon with the FDA for Implantable Clip.
| Device ID | K100090 |
| 510k Number | K100090 |
| Device Name: | IMPLANTABLE CLIP |
| Classification | Clip, Implantable |
| Applicant | GENICON 6869 STAPOINT CT., SUITE 114 Winter Park, FL 32792 |
| Contact | Gary Haberland |
| Correspondent | Gary Haberland GENICON 6869 STAPOINT CT., SUITE 114 Winter Park, FL 32792 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-12 |
| Decision Date | 2010-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877972004578 | K100090 | 000 |
| 00877972004554 | K100090 | 000 |
| 00877972004530 | K100090 | 000 |
| 00877972004516 | K100090 | 000 |