Submission Details
| 510(k) Number | K874774 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 1987 |
| Decision Date | February 08, 1988 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K874774 is an FDA 510(k) clearance for the TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS, a Trousers, Anti-shock (Class II — Special Controls, product code LHX), submitted by Vinyl Technology, Inc. (So. El Monte, US). The FDA issued a Cleared decision on February 8, 1988, 81 days after receiving the submission on November 19, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K874774 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 1987 |
| Decision Date | February 08, 1988 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | LHX — Trousers, Anti-shock |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5800 |