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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, collagen
510(k) Number K120339
Device Name PROCOLL
Original Applicant
INNOCOLL PHARMACEUTICALS
dublin road
athlone, co. westmeath,  IE
Original Contact aaron wyse
Classification Product Code
KGN  
Date Received02/03/2012
Decision Date 06/21/2012
Decision substantially equivalent (SESE)
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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