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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(k) Number K060329
Device Name ENDOFAST RELIANT SYSTEM
Applicant
ENDOGUN MEDICAL SYSTEMS
C/O YORAM LEVY
31 HAAVODA STREET
BINYAMINA,  IL 30500
Applicant Contact YORAM LEVY
Correspondent
ENDOGUN MEDICAL SYSTEMS
C/O YORAM LEVY
31 HAAVODA STREET
BINYAMINA,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
GDW  
Date Received02/09/2006
Decision Date 09/11/2006
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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