K963378 is an FDA 510(k) clearance for the MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER. This device is classified as a Restraint, Protective (Class I - General Controls, product code FMQ).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on October 29, 1996, 63 days after receiving the submission on August 27, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6760.
| 510(k) Number | K963378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1996 |
| Decision Date | October 29, 1996 |
| Days to Decision | 63 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 |