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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Flexible
510(k) Number K020891
Device Name NAKAO SNARE II AND NAKAO SNARE III
Applicant
GRANIT MEDICAL INNOVATIONS
992 FIFTH AVE.
NEW YORK,  NY  10028
Applicant Contact NAOMI L NAKAO
Correspondent
GRANIT MEDICAL INNOVATIONS
992 FIFTH AVE.
NEW YORK,  NY  10028
Correspondent Contact NAOMI L NAKAO
Regulation Number876.4300
Classification Product Code
FDI  
Date Received03/19/2002
Decision Date 06/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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