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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 K033869
Device Name CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
Applicant
COLOPLAST CORP.
1940 COMMERCE DR.
NORTH MANKATO,  MN  56003
Applicant Contact ELIZABETH BOOTS
Correspondent
COLOPLAST CORP.
1940 COMMERCE DR.
NORTH MANKATO,  MN  56003
Correspondent Contact ELIZABETH BOOTS
Classification Product Code
FRO  
Date Received12/12/2003
Decision Date 05/17/2004
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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