K110377 is an FDA 510(k) clearance for the PROTECTIVE RESTRAINT. This device is classified as a Restraint, Protective (Class I - General Controls, product code FMQ).
Submitted by Medi-Tech Intl. Corp. (Brooklyn, US). The FDA issued a Cleared decision on April 25, 2011, 75 days after receiving the submission on February 9, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6760.
| 510(k) Number | K110377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2011 |
| Decision Date | April 25, 2011 |
| Days to Decision | 75 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 |