The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Osteoguide Anorganic Bone Mineral Products.
| Device ID | K043034 |
| 510k Number | K043034 |
| Device Name: | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Contact | Peggy Hansen |
| Correspondent | Peggy Hansen COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-03 |
| Decision Date | 2005-08-04 |
| Summary: | summary |