K963477 is an FDA 510(k) clearance for the PEDIATRIC MITTENS. 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 November 12, 1996, 70 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 | K963477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1996 |
| Decision Date | November 12, 1996 |
| Days to Decision | 70 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 |