Cleared Special

CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL

K133764 · Avery Dennison Belgie Bvba · General & Plastic Surgery
Mar 2014
Decision
92d
Days
—
Risk

About This 510(k) Submission

K133764 is an FDA 510(k) clearance for the CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL, a Dressing, Wound, Drug, submitted by Avery Dennison Belgie Bvba (Turnhout, BE). The FDA issued a Cleared decision on March 13, 2014, 92 days after receiving the submission on December 11, 2013. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K133764 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2013
Decision Date March 13, 2014
Days to Decision 92 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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