The following data is part of a premarket notification filed by Fla. Orthopedics, Inc. with the FDA for Patient Restraint.
| Device ID | K970272 |
| 510k Number | K970272 |
| Device Name: | PATIENT RESTRAINT |
| Classification | Restraint, Protective |
| Applicant | FLA. ORTHOPEDICS, INC. 5858 N.W. 158TH ST., P.O. BOX 5380 Miami Lakes, FL 33014 -1380 |
| Contact | Rhonda Falk |
| Correspondent | Rhonda Falk FLA. ORTHOPEDICS, INC. 5858 N.W. 158TH ST., P.O. BOX 5380 Miami Lakes, FL 33014 -1380 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-23 |
| Decision Date | 1997-04-11 |