The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Anorganic Bone Mineral With Collagen In Delivery Applicator.
| Device ID | K171008 |
| 510k Number | K171008 |
| Device Name: | Anorganic Bone Mineral With Collagen In Delivery Applicator |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | Collagen Matrix, Inc. 15 Thornton Road Oakland, NJ 07436 |
| Contact | Danielle Lindner |
| Correspondent | Danielle Lindner Collagen Matrix, Inc. 15 Thornton Road Oakland, NJ 07436 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-04 |
| Decision Date | 2017-10-30 |
| Summary: | summary |