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FDA 510(k) Application Details - K992141
Device Classification Name
Resectoscope, Working Element
More FDA Info for this Device
510(K) Number
K992141
Device Name
Resectoscope, Working Element
Applicant
OLYMPUS WINTER & IBE GMBH
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
Other 510(k) Applications for this Company
Contact
LAURA STORMS-TYLER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FDC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/1999
Decision Date
09/29/1999
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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