Cleared Traditional

K172570 - ALGS6 Ag Alginate Wound Dressing (FDA 510(k) Clearance)

May 2018
Decision
256d
Days
-
Risk

K172570 is an FDA 510(k) clearance for the ALGS6 Ag Alginate Wound Dressing. This device is classified as a Dressing, Wound, Drug.

Submitted by Foshan United Medical Technologies, Ltd. (Foshan, CN). The FDA issued a Cleared decision on May 11, 2018, 256 days after receiving the submission on August 28, 2017.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K172570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2017
Decision Date May 11, 2018
Days to Decision 256 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO - Dressing, Wound, Drug
Device Class -

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