The following data is part of a premarket notification filed by Zimmer Patient Care Division with the FDA for Economy Safety Vest Restraint, Shoulder Tie Safety Vest/safety Vest Restraint, Heavy Duty Vest Restraint, Mesh Safety Ve.
| Device ID | K963435 |
| 510k Number | K963435 |
| Device Name: | ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE |
| Classification | Restraint, Protective |
| Applicant | ZIMMER PATIENT CARE DIVISION 200 WEST OHIO AVE. P.O.BOX 10 Dover, OH 44622 |
| Contact | Paul Osorio |
| Correspondent | Paul Osorio ZIMMER PATIENT CARE DIVISION 200 WEST OHIO AVE. P.O.BOX 10 Dover, OH 44622 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1996-11-06 |
| Summary: | summary |