Cleared Traditional

MEPILEX TRANSFER AG

K123892 · Molnlycke Health Care · General & Plastic Surgery
Apr 2013
Decision
108d
Days
Risk

About This 510(k) Submission

K123892 is an FDA 510(k) clearance for the MEPILEX TRANSFER AG, a Dressing, Wound, Drug, submitted by Molnlycke Health Care (Norcross, US). The FDA issued a Cleared decision on April 5, 2013, 108 days after receiving the submission on December 18, 2012. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K123892 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2012
Decision Date April 05, 2013
Days to Decision 108 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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