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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
INNONOLL PHARMACEUTICALS LTD.
midlands research and
innovation centre, dublin rd
athlone,  EI ei
Original Contact aaron wyse
Classification Product Code
KGN  
Date Received02/07/2012
Decision Date 06/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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