The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Dental Wound Dressings.
| Device ID | K152600 |
| 510k Number | K152600 |
| Device Name: | Collagen Dental Wound Dressings |
| Classification | Dressing, Wound, Collagen |
| Applicant | COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland, NJ 07436 |
| Contact | Gloria Zuclich |
| Correspondent | Gloria Zuclich COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland, NJ 07436 |
| 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 | 2015-09-11 |
| Decision Date | 2016-06-23 |
| Summary: | summary |