The following data is part of a premarket notification filed by Femasys Inc. with the FDA for Femvue(tm) Catheter System.
| Device ID | K083690 |
| 510k Number | K083690 |
| Device Name: | FEMVUE(TM) CATHETER SYSTEM |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | FEMASYS INC. 5000 RESEARCH COURT STE .100 Suwanee, GA 30024 |
| Contact | Marc Finch |
| Correspondent | Marc Finch FEMASYS INC. 5000 RESEARCH COURT STE .100 Suwanee, GA 30024 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-12 |
| Decision Date | 2009-06-23 |
| Summary: | summary |