The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Dura Membrane.
| Device ID | K141608 |
| 510k Number | K141608 |
| Device Name: | COLLAGEN DURA MEMBRANE |
| Classification | Dura Substitute |
| 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 | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-16 |
| Decision Date | 2015-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813954020426 | K141608 | 000 |
| 00813954020419 | K141608 | 000 |
| 00813954020402 | K141608 | 000 |
| 00813954020396 | K141608 | 000 |
| 00813954020389 | K141608 | 000 |