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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, 
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 (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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