K963456 is an FDA 510(k) clearance for the LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER. This device is classified as a Restraint, Protective (Class I - General Controls, product code FMQ).
Submitted by Skil-Care Corp. (Yonkers, US). The FDA issued a Cleared decision on October 8, 1996, 35 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 | K963456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1996 |
| Decision Date | October 08, 1996 |
| Days to Decision | 35 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 |