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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 K063059
Device Name SORBACT WOUND DRESSING
Applicant
ABIGO MEDICAL AB
1601 K STREET NW
WASHINGTON,  DC  20006
Applicant Contact EMALEE G MURPHY
Correspondent
ABIGO MEDICAL AB
1601 K STREET NW
WASHINGTON,  DC  20006
Correspondent Contact EMALEE G MURPHY
Classification Product Code
FRO  
Date Received10/05/2006
Decision Date 04/19/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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