The following data is part of a premarket notification filed by Unimar, Inc. with the FDA for Kdf-2.3.
| Device ID | K894264 |
| 510k Number | K894264 |
| Device Name: | KDF-2.3 |
| Classification | Cap, Cervical |
| Applicant | UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Contact | Anthony Hemming |
| Correspondent | Anthony Hemming UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-20 |
| Decision Date | 1989-08-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() KDF-2.3 74088187 1661597 Dead/Cancelled |
Unimar, Inc. 1990-08-15 |