The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Porcine Anorganic Bone Mineral.
Device ID | K140714 |
510k Number | K140714 |
Device Name: | PORCINE ANORGANIC BONE MINERAL |
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 | 2014-03-21 |
Decision Date | 2014-07-16 |
Summary: | summary |