Cleared Traditional

KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662

K070685 · Tyco Healthcare · General & Plastic Surgery
Sep 2007
Decision
186d
Days
Risk

About This 510(k) Submission

K070685 is an FDA 510(k) clearance for the KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662, a Dressing, Wound, Drug, submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on September 14, 2007, 186 days after receiving the submission on March 12, 2007. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K070685 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2007
Decision Date September 14, 2007
Days to Decision 186 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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