K961083 is an FDA 510(k) clearance for the OREX SURGEON'S VEST. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Thantex Specialties, Inc. (Norcross, US). The FDA issued a Cleared decision on August 23, 1996, 157 days after receiving the submission on March 19, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K961083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1996 |
| Decision Date | August 23, 1996 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |