Cleared Special

SILVER ANTIMICROBIAL WOUND GEL

K110458 · Advanced Medical Solutions Limited · General & Plastic Surgery
Mar 2011
Decision
25d
Days
—
Risk

About This 510(k) Submission

K110458 is an FDA 510(k) clearance for the SILVER ANTIMICROBIAL WOUND GEL, a Dressing, Wound, Drug, submitted by Advanced Medical Solutions Limited (Winsford Cheshire, GB). The FDA issued a Cleared decision on March 14, 2011, 25 days after receiving the submission on February 17, 2011. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K110458 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2011
Decision Date March 14, 2011
Days to Decision 25 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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

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