K963404 is an FDA 510(k) clearance for the MEDLINE PELVIC 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 18, 1996, 50 days after receiving the submission on August 29, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6760.
| 510(k) Number | K963404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1996 |
| Decision Date | October 18, 1996 |
| Days to Decision | 50 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 |