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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 K122325
Device Name SKINTEMP II
Original Applicant
HUMAN BIOSCIENCES, INC.
2913, 209th lane nw
oak grove,  MN  55011
Original Contact jack slovick
Classification Product Code
KGN  
Date Received08/06/2012
Decision Date 10/26/2012
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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