K953763 is an FDA 510(k) clearance for the GLADIATOR ANTISHOCK PANTS. This device is classified as a Trousers, Anti-shock (Class II - Special Controls, product code LHX).
Submitted by Jobst Institute, Inc. (Charlotte, US). The FDA issued a Cleared decision on November 28, 1995, 109 days after receiving the submission on August 11, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K953763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1995 |
| Decision Date | November 28, 1995 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | LHX — Trousers, Anti-shock |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |