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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 K002927
Device Name SNARE,FLEXIBLE
Applicant
ODON LIFETECHNOLOGY
2 BIS RUE DU COMMANDANT PILOT
NEUILLY SUR SEINE,  FR 92200
Applicant Contact J M DURAND
Correspondent
ODON LIFETECHNOLOGY
2 BIS RUE DU COMMANDANT PILOT
NEUILLY SUR SEINE,  FR 92200
Correspondent Contact J M DURAND
Regulation Number876.4300
Classification Product Code
FDI  
Date Received09/20/2000
Decision Date 12/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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