The following data is part of a premarket notification filed by Weihai Hongyu Nonwoven Fabric Products Co., Ltd with the FDA for Hongyu Disposable Surgical Drapes.
| Device ID | K141324 |
| 510k Number | K141324 |
| Device Name: | HONGYU DISPOSABLE SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-20 |
| Decision Date | 2015-04-14 |
| Summary: | summary |