The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Duramatrix Collagen Dura Substitute Membrane.
| Device ID | K040888 |
| 510k Number | K040888 |
| Device Name: | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE |
| Classification | Dura Substitute |
| Applicant | COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Contact | Peggy Hansen |
| Correspondent | Peggy Hansen COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-05 |
| Decision Date | 2004-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813954022499 | K040888 | 000 |
| 00813954020198 | K040888 | 000 |
| 00813954020204 | K040888 | 000 |
| 00813954020211 | K040888 | 000 |
| 00813954020228 | K040888 | 000 |
| 00813954022451 | K040888 | 000 |
| 00813954022468 | K040888 | 000 |
| 00813954022475 | K040888 | 000 |
| 00813954022482 | K040888 | 000 |
| 00813954020181 | K040888 | 000 |