K133080 is an FDA 510(k) clearance for the Plus Surgical Drapes (EO Sterilized), PMDB-XXX. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Foshan Nanhai Plus Medical Co, Ltd. (Dover, US). The FDA issued a Cleared decision on June 24, 2015, 632 days after receiving the submission on September 30, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K133080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2013 |
| Decision Date | June 24, 2015 |
| Days to Decision | 632 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 |