K980183 is an FDA 510(k) clearance for the PROMAX SURGICAL DRAPES AND COVERS. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 26, 1998, 37 days after receiving the submission on January 20, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K980183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 1998 |
| Decision Date | February 26, 1998 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |