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FDA 510(k) Application Details - K002028
Device Classification Name
Electrode, Ph, Stomach
More FDA Info for this Device
510(K) Number
K002028
Device Name
Electrode, Ph, Stomach
Applicant
ENDONETICS, INC.
987 UNIVERSITY AVE.;STE. 14
LOS GATOS, CA 95032 US
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Contact
WILLIAM A KNAPE
Other 510(k) Applications for this Contact
Regulation Number
876.1400
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Classification Product Code
FFT
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More FDA Info for this Product Code
Date Received
07/03/2000
Decision Date
09/29/2000
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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