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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 K100591
Device Name SORBACT
Applicant
ABIGO MEDICAL AB
435 RICE CREEK TERRACE NE,
FRIDLEY,  MN  55432
Applicant Contact CONSTANCE BUNDY
Correspondent
ABIGO MEDICAL AB
435 RICE CREEK TERRACE NE,
FRIDLEY,  MN  55432
Correspondent Contact CONSTANCE BUNDY
Classification Product Code
FRO  
Date Received03/02/2010
Decision Date 01/24/2011
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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