K141324 is an FDA 510(k) clearance for the HONGYU DISPOSABLE SURGICAL DRAPES. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 14, 2015, 329 days after receiving the submission on May 20, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K141324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2014 |
| Decision Date | April 14, 2015 |
| Days to Decision | 329 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 |