The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Topical Wound Dressing.
| Device ID | K030921 |
| 510k Number | K030921 |
| Device Name: | COLLAGEN TOPICAL WOUND DRESSING |
| 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 | 2003-03-24 |
| Decision Date | 2003-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005565208 | K030921 | 000 |
| 00850005565581 | K030921 | 000 |
| 00850005565437 | K030921 | 000 |
| 00850005565413 | K030921 | 000 |
| 00850005565383 | K030921 | 000 |