FDA 510(k) Application Details - K992114

Device Classification Name Lithotriptor, Electro-Hydraulic

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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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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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