The following data is part of a premarket notification filed by Modern Healthcare Corp. with the FDA for Motex Anti-fog Surgical Face Mask.
| Device ID | K201549 |
| 510k Number | K201549 |
| Device Name: | Motex Anti-Fog Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Modern Healthcare Corp. NO. 751, Sec. 2, Chung-Chou Rd., Tien-chung Town, Chang-hwa County, TW 52045 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen Chinese European Industrial Research Society No. 58, Fu-Chiun St Hsin-chu City, TW 30067 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-09 |
| Decision Date | 2020-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042014352 | K201549 | 000 |