The following data is part of a premarket notification filed by Hong Ya Non-woven Products Co., Ltd. with the FDA for Surgical Face Mask.
| Device ID | K043199 |
| 510k Number | K043199 |
| Device Name: | SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | HONG YA NON-WOVEN PRODUCTS CO., LTD. 3973 SCHAEFER AVE. Chino, CA 91710 |
| Contact | James Chu |
| Correspondent | James Chu HONG YA NON-WOVEN PRODUCTS CO., LTD. 3973 SCHAEFER AVE. Chino, CA 91710 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-18 |
| Decision Date | 2005-02-16 |
| Summary: | summary |