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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Staple, Implantable
510(k) Number K060494
Device Name EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
Applicant
MEDCHANNEL, LLC
55 WORCESTER STREET, #3
BOSTON,  MA  02118
Applicant Contact FREDERICK TOBIA
Correspondent
MEDCHANNEL, LLC
55 WORCESTER STREET, #3
BOSTON,  MA  02118
Correspondent Contact FREDERICK TOBIA
Regulation Number878.4750
Classification Product Code
GDW  
Date Received02/24/2006
Decision Date 07/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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