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 |