The following data is part of a premarket notification filed by Unimar, Inc. with the FDA for Kronner Manipujector.
| Device ID | K904473 |
| 510k Number | K904473 |
| Device Name: | KRONNER MANIPUJECTOR |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| 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 | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-01 |
| Decision Date | 1990-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937014765 | K904473 | 000 |
| 00888937015805 | K904473 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() KRONNER MANIPUJECTOR 74332997 1861723 Live/Registered |
Kronner, Richard F. 1992-11-20 |