The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Dental Mambrane - Porcine Type I Collagen.
| Device ID | K110600 |
| 510k Number | K110600 |
| Device Name: | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN |
| 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 | 2011-03-02 |
| Decision Date | 2011-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841336112056 | K110600 | 000 |
| 00841336112049 | K110600 | 000 |
| 00841336112032 | K110600 | 000 |