K122000 is an FDA 510(k) clearance for the HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Changzhou Holymed Products Co., Ltd. (Changhou, CN). The FDA issued a Cleared decision on December 12, 2012, 156 days after receiving the submission on July 9, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K122000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2012 |
| Decision Date | December 12, 2012 |
| Days to Decision | 156 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 |