The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Vest Restraint.
| Device ID | K760868 |
| 510k Number | K760868 |
| Device Name: | VEST RESTRAINT |
| Classification | Instrument, Biopsy |
| Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-18 |
| Decision Date | 1976-11-01 |