The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Dental Membrane - Conformable Iibp.
| Device ID | K142496 |
| 510k Number | K142496 |
| Device Name: | Collagen Dental Membrane - Conformable IIBP |
| Classification | Barrier, Animal Source, Intraoral |
| 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 | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-05 |
| Decision Date | 2014-11-24 |
| Summary: | summary |