The following data is part of a premarket notification filed by Unimar, Inc. with the FDA for Uni-sem(tm).
| Device ID | K910317 |
| 510k Number | K910317 |
| Device Name: | UNI-SEM(TM) |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Contact | Edward C Vollmer |
| Correspondent | Edward C Vollmer UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-24 |
| Decision Date | 1991-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937003462 | K910317 | 000 |
| 20888937001222 | K910317 | 000 |
| 20888937001215 | K910317 | 000 |