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FDA 510(k) Application Details - K962506
Device Classification Name
Resectoscope
More FDA Info for this Device
510(K) Number
K962506
Device Name
Resectoscope
Applicant
GYNECARE INNOVATION CENTER
1221 INNSBRUCK DR.
SUNNYVALE, CA 94089 US
Other 510(k) Applications for this Company
Contact
MICHAEL A DANIEL
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FJL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/27/1996
Decision Date
09/16/1996
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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