K020435 is an FDA 510(k) clearance for the WOUND PROTECTOR/RETRACTOR. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on April 15, 2002, 66 days after receiving the submission on February 8, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K020435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2002 |
| Decision Date | April 15, 2002 |
| Days to Decision | 66 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 |