The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Wound Dressing - Oral.
| Device ID | K040403 |
| 510k Number | K040403 |
| Device Name: | COLLAGEN WOUND DRESSING - ORAL |
| Classification | Dressing, Wound, Collagen |
| Applicant | COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Contact | Peggy Hansen |
| Correspondent | Peggy Hansen COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-05-10 |
| Summary: | summary |