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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fiber, medical, absorbent
510(k) Number K121898
Device Name STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
Original Applicant
QUICK-MED TECHNOLOGIES, INC.
49 plain street
north attleboro,  MA  02760
Original Contact mary mcnamara-cullinane
Regulation Number880.5300
Classification Product Code
FRL  
Date Received06/29/2012
Decision Date 05/24/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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