The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Mineral Collagen Composite Bioactive Moldable.
| Device ID | K182074 |
| 510k Number | K182074 |
| Device Name: | Mineral Collagen Composite Bioactive Moldable |
| Classification | Filler, Bone Void, Calcium Compound |
| 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 | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-01 |
| Decision Date | 2019-03-21 |