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FDA 510(k) Application Details - K123151
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K123151
Device Name
Hysteroscope (And Accessories)
Applicant
ENDOSEE CORP
4546 EL CAMINO REAL,
SUITE 215
LOS ALTOS, CA 94022 US
Other 510(k) Applications for this Company
Contact
XIAOLONG(BRUCE) OUYANG
Other 510(k) Applications for this Contact
Regulation Number
884.1690
More FDA Info for this Regulation Number
Classification Product Code
HIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/09/2012
Decision Date
03/08/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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