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FDA 510(k) Application Details - K040961
Device Classification Name
Snare, Flexible
More FDA Info for this Device
510(K) Number
K040961
Device Name
Snare, Flexible
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR, OH 44060 US
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Contact
GRETCHEN Y COHEN
Other 510(k) Applications for this Contact
Regulation Number
876.4300
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Classification Product Code
FDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2004
Decision Date
07/08/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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