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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
Applicant
CURALINE INC
10554 NORTH WASHINGTON PORT ROAD
MEQUON,  WI  53092
Applicant Contact HAITHAM MATLOUB
Correspondent
CURALINE INC
10554 NORTH WASHINGTON PORT ROAD
MEQUON,  WI  53092
Correspondent Contact HAITHAM MATLOUB
Classification Product Code
FRO  
Date Received05/07/2012
Decision Date 11/30/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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