The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Orthotech Heavy Duty Vest Restraint.
| Device ID | K971742 |
| 510k Number | K971742 |
| Device Name: | DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT |
| Classification | Restraint, Protective |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Arlene C Saull |
| Correspondent | Arlene C Saull DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-12 |
| Decision Date | 1997-07-24 |
| Summary: | summary |