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 |