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 |