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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 K122462
Device Name ROTH NET RETRIEVER
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisely rd.
mentor,  OH  44060
Contact carroll martin
Regulation Number876.4300
Classification Product Code
FDI  
Subsequent Product Code
GCJ  
Date Received08/13/2012
Decision Date 09/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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