The following data is part of a premarket notification filed by Femasys Inc. with the FDA for Femvue Saline-air Device.
| Device ID | K110288 |
| 510k Number | K110288 |
| Device Name: | FEMVUE SALINE-AIR DEVICE |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | FEMASYS INC. 5000 RESEARCH COURT STE .100 Suwanee, GA 30024 |
| Contact | Lisa Peacock |
| Correspondent | Lisa Peacock 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 | 2011-02-01 |
| Decision Date | 2011-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859500005004 | K110288 | 000 |