FDA 510(k) Premarket Notification K143462: AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)

Submission Details & Decision

Normalized public record details for 510(k) notification K143462.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K143462

Applicant / Sponsor

Benq Materials Corporation

Device Name

AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)

Product Code

QSY

Decision Date

2015-05-08

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Unknown ()

Clearance Type

Traditional

Third Party Flag

Date Received

2014-12-04

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