The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Dental Membrane - Conformable Pp.
| Device ID | K141909 |
| 510k Number | K141909 |
| Device Name: | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland, NJ 07436 |
| Contact | Peggy Hansen |
| Correspondent | Peggy Hansen COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland, NJ 07436 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-15 |
| Decision Date | 2014-11-05 |
| Summary: | summary |