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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 K122502
Device Name BRIDGE EXTRACELLULAR COLLEGEN MATRIX
Applicant
HARBOR MEDTECH, INC.
4 jenner
suite 190
irvine,  CA  92618
Contact jerry mezger
Classification Product Code
KGN  
Date Received08/16/2012
Decision Date 02/26/2013
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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