The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Osteotech Musculoskeletal Tissue Recovery Pack.
| Device ID | K951811 |
| 510k Number | K951811 |
| Device Name: | OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK |
| Classification | Tray, Surgical |
| Applicant | OSTEOTECH, INC. 1151 SHREWSBURY AVE. Shrewsbury, NJ 07702 |
| Contact | Christopher Talbot |
| Correspondent | Christopher Talbot OSTEOTECH, INC. 1151 SHREWSBURY AVE. Shrewsbury, NJ 07702 |
| Product Code | LRP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-19 |
| Decision Date | 1995-05-31 |