The following data is part of a premarket notification filed by Jemm Medical Products with the FDA for Provest-protective Restraint.
| Device ID | K971561 |
| 510k Number | K971561 |
| Device Name: | PROVEST-PROTECTIVE RESTRAINT |
| Classification | Restraint, Protective |
| Applicant | JEMM MEDICAL PRODUCTS 42909 ALEP ST. Lancaster, CA 93536 |
| Contact | Angelita Kowalewsky |
| Correspondent | Angelita Kowalewsky JEMM MEDICAL PRODUCTS 42909 ALEP ST. Lancaster, CA 93536 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-29 |
| Decision Date | 1997-07-14 |