The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Bone Healing Protective Sheet.
| Device ID | K052041 |
| 510k Number | K052041 |
| Device Name: | COLLAGEN BONE HEALING PROTECTIVE SHEET |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| Subsequent Product Code | FTM |
| Subsequent Product Code | LZN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-28 |
| Decision Date | 2005-10-25 |
| Summary: | summary |