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FDA 510(k) Application Details - K992114
Device Classification Name
Lithotriptor, Electro-Hydraulic
More FDA Info for this Device
510(K) Number
K992114
Device Name
Lithotriptor, Electro-Hydraulic
Applicant
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact
KEVIN A KENNAN
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Regulation Number
876.4480
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Classification Product Code
FFK
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More FDA Info for this Product Code
Date Received
06/22/1999
Decision Date
08/18/1999
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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