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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dressing, wound, drug
510(k) Number K122634
Device Name IODOFOAM IODOPHOR FOAM DRESSING
Original Applicant
PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC
150 levinberg lane
wayne,  NJ  07470
Original Contact mason diamond
Classification Product Code
FRO  
Date Received08/29/2012
Decision Date 03/12/2013
Decision substantially equivalent (SE)
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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