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FDA 510(k) Application Details - K101298
Device Classification Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
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510(K) Number
K101298
Device Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant
ENDOCHOICE, INC.
11800 WILLIS RD
SUITE 100
ALPHARETTA, GA 30009 US
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Contact
THERON GOBER
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Regulation Number
876.1500
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Classification Product Code
OCZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/10/2010
Decision Date
08/05/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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