The following data is part of a premarket notification filed by Smith And Nephew Donjoy, Inc. with the FDA for Protective Restraint - Belts.
| Device ID | K963490 |
| 510k Number | K963490 |
| Device Name: | PROTECTIVE RESTRAINT - BELTS |
| Classification | Restraint, Protective |
| Applicant | SMITH AND NEPHEW DONJOY, INC. 2985 SCOTT ST. Vista, CA 92083 |
| Contact | Dan W Miller |
| Correspondent | Dan W Miller SMITH AND NEPHEW DONJOY, INC. 2985 SCOTT ST. Vista, CA 92083 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-11-12 |
| Summary: | summary |