Cleared Traditional

SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER

K121819 · Covalontechnologies, Inc. · General & Plastic Surgery
Aug 2012
Decision
53d
Days
—
Risk

About This 510(k) Submission

K121819 is an FDA 510(k) clearance for the SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER, a Dressing, Wound, Drug, submitted by Covalontechnologies, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on August 13, 2012, 53 days after receiving the submission on June 21, 2012. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K121819 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2012
Decision Date August 13, 2012
Days to Decision 53 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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