K963463 is an FDA 510(k) clearance for the STRAIT JACKET. This device is classified as a Restraint, Protective (Class I - General Controls, product code FMQ).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on October 16, 1996, 43 days after receiving the submission on September 3, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6760.
| 510(k) Number | K963463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1996 |
| Decision Date | October 16, 1996 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMQ — Restraint, Protective |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6760 |