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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
Applicant
Quick-Med Technologies, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Quick-Med Technologies, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number880.5300
Classification Product Code
FRL  
Date Received06/29/2012
Decision Date 05/24/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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