The following data is part of a premarket notification filed by Benq Materials Corporation with the FDA for Anscare Chitoclot Pad.
Device ID | K150963 |
510k Number | K150963 |
Device Name: | AnsCare ChitoClot Pad |
Classification | Dressing, Wound, Drug |
Applicant | BENQ MATERIALS CORPORATION NO. 29, JIANGUO E. RD GUISHAN Taoyuan, TW 33341 |
Contact | Kenix Chang |
Correspondent | Kenix Chang BENQ MATERIALS CORPORATION NO. 29, JIANGUO E. RD GUISHAN Taoyuan, TW 33341 |
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 | 2015-04-10 |
Decision Date | 2015-11-05 |
Summary: | summary |