The following data is part of a premarket notification filed by Benq Materials Corporation with the FDA for Anscare Chitoclot Gauze (prescription Use), Anscare Chitoclot Gauze (over-the-counter Use).
| Device ID | K143462 |
| 510k Number | K143462 |
| Device Name: | AnsCare ChitoClot Gauze (prescription Use), AnsCare ChitoClot Gauze (over-the-counter Use) |
| Classification | Dressing, Wound, Drug |
| Applicant | BENQ MATERIALS CORPORATION NO. 29, JIANGUO E. RD GUISHAN Taoyuan, TW 33341 |
| Contact | Kenix Chang |
| Correspondent | Kenix Chang ACMEBIOTECHS CO., LTD 29, Jianguo E. Rd., Gueishan 33341 Taoyuan Taiwan, TW |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-04 |
| Decision Date | 2015-05-08 |
| Summary: | summary |