The following data is part of a premarket notification filed by E.m. Adams Co., Inc. with the FDA for Restraints (vests And Jackets).
| Device ID | K971536 |
| 510k Number | K971536 |
| Device Name: | RESTRAINTS (VESTS AND JACKETS) |
| Classification | Restraint, Protective |
| Applicant | E.M. ADAMS CO., INC. 7496 COMMERCIAL CIRCLE Fort Pierce, FL 34951 |
| Contact | Richard K Donahue |
| Correspondent | Richard K Donahue E.M. ADAMS CO., INC. 7496 COMMERCIAL CIRCLE Fort Pierce, FL 34951 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-07-01 |