Cleared Traditional

BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)

K113836 · Avery Dennison Belgie Bvba · General & Plastic Surgery
Sep 2012
Decision
271d
Days
Risk

About This 510(k) Submission

K113836 is an FDA 510(k) clearance for the BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM), a Dressing, Wound, Drug, submitted by Avery Dennison Belgie Bvba (Chicago, US). The FDA issued a Cleared decision on September 24, 2012, 271 days after receiving the submission on December 28, 2011. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K113836 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2011
Decision Date September 24, 2012
Days to Decision 271 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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