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 |