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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, drug
510(k) Number K121361
Device Name CURALINE POLYURETHANE FOAM AWC DRESSING
Original Applicant
CURALINE INC
10554 north washington port road
mequon,  WI  53092
Original Contact haitham matloub
Classification Product Code
FRO  
Date Received05/07/2012
Decision Date 11/30/2012
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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