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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
dublin road
athlone, co. westmeath,  IE
Original Contact aaron wyse
Classification Product Code
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