ALLOPREP SYSTEM
Media And Components, Synthetic Cell And Tissue Culture
OSTEOTECH, INC.
The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Alloprep System.
Pre-market Notification Details
| Device ID | K883065 |
| 510k Number | K883065 |
| Device Name: | ALLOPREP SYSTEM |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | OSTEOTECH, INC. 1151 E SHEREWSBURY AVE. Shrewsbury, NJ 07702 |
| Contact | Chen, Phd |
| Correspondent | Chen, Phd OSTEOTECH, INC. 1151 E SHEREWSBURY AVE. Shrewsbury, NJ 07702 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-20 |
| Decision Date | 1988-10-13 |
Trademark Results [ALLOPREP SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALLOPREP SYSTEM 73775509 1569178 Dead/Expired |
OSTEOTECH, INC. 1989-01-19 |
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