The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Porcine Anorganic Bone Mineral In Delivery Applicator.
| Device ID | K162158 |
| 510k Number | K162158 |
| Device Name: | Porcine Anorganic Bone Mineral In Delivery Applicator |
| Classification | Bone Grafting Material, Animal Source |
| 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 | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-02 |
| Decision Date | 2017-02-09 |
| Summary: | summary |