The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Matrix Anorganic Bone Mineral Bone Graft Materials.
| Device ID | K062200 |
| 510k Number | K062200 |
| Device Name: | COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Contact | Peggy Hanson |
| Correspondent | Peggy Hanson COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-01 |
| Decision Date | 2007-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813954022253 | K062200 | 000 |
| 00813954022246 | K062200 | 000 |
| 00813954020303 | K062200 | 000 |
| 00813954020297 | K062200 | 000 |