Cleared Traditional

K120930 - CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING (FDA 510(k) Clearance)

Oct 2012
Decision
213d
Days
Risk

K120930 is an FDA 510(k) clearance for the CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING. This device is classified as a Dressing, Wound, Drug.

Submitted by Medtrade Products , Ltd. (Cheshire, GB). The FDA issued a Cleared decision on October 26, 2012, 213 days after receiving the submission on March 27, 2012.

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

Submission Details

510(k) Number K120930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2012
Decision Date October 26, 2012
Days to Decision 213 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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