Cleared Traditional

SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND

K091013 · Advanced Medical Solutions Limited · General & Plastic Surgery

Jul 2009

Decision

112d

Days

—

Risk

About This 510(k) Submission

K091013 is an FDA 510(k) clearance for the SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND, a Dressing, Wound, Drug, submitted by Advanced Medical Solutions Limited (Winsford, Cheshire, GB). The FDA issued a Cleared decision on July 30, 2009, 112 days after receiving the submission on April 9, 2009. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K091013 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 2009
Decision Date	July 30, 2009
Days to Decision	112 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF