The following data is part of a premarket notification filed by Osteo-technology Intl., Inc. with the FDA for Oti European Compression System.
| Device ID | K925571 |
| 510k Number | K925571 |
| Device Name: | OTI EUROPEAN COMPRESSION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | OSTEO-TECHNOLOGY INTL., INC. 10 WEST AYLESBURY RD. Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son OSTEO-TECHNOLOGY INTL., INC. 10 WEST AYLESBURY RD. Timonium, MD 21093 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-03 |
| Decision Date | 1993-07-13 |