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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 K080836
Device Name MODIFICATION TO ENDOFAST RELIANT SYSTEM
Applicant
ENDOGUN MEDICAL SYSTEMS
jabotinsky street 7
ramat gan,  IL 52520
Applicant Contact dorit winitz
Correspondent
ENDOGUN MEDICAL SYSTEMS
jabotinsky street 7
ramat gan,  IL 52520
Correspodent Contact dorit winitz
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/25/2008
Decision Date 04/21/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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