K950830 is an FDA 510(k) clearance for the STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Avail-Southwest Division (Dallas, US). The FDA issued a Cleared decision on May 3, 1995, 68 days after receiving the submission on February 24, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K950830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1995 |
| Decision Date | May 03, 1995 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |