K963362 is an FDA 510(k) clearance for the MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT. 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 18, 1996, 53 days after receiving the submission on August 26, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6760.
| 510(k) Number | K963362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1996 |
| Decision Date | October 18, 1996 |
| Days to Decision | 53 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 |