K780232 is an FDA 510(k) clearance for the RESTRAINT, PROTECTIVE. This device is classified as a Restraint, Protective (Class I - General Controls, product code FMQ).
Submitted by Biomet, Inc. (Walker, US). The FDA issued a Cleared decision on February 21, 1978, 12 days after receiving the submission on February 9, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6760.
| 510(k) Number | K780232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1978 |
| Decision Date | February 21, 1978 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMQ — Restraint, Protective |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6760 |