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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
Original Applicant
ENDOGUN MEDICAL SYSTEMS
c/o yoram levy
31 haavoda street
binyamina,  IL 30500
Original Contact yoram levy
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Codes
GDW   KOG  
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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