K822641 is an FDA 510(k) clearance for the GORE-TEX BARRIER SURG. DRAPES & GOWNS. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by W.L. Gore & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983, 128 days after receiving the submission on September 1, 1982.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K822641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1982 |
| Decision Date | January 07, 1983 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |