K023432 is an FDA 510(k) clearance for the MEDLINE ASEP PLUS SURGICAL DRAPES. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 4, 2002, 20 days after receiving the submission on October 15, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K023432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2002 |
| Decision Date | November 04, 2002 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |