FDA 510(k) Application Details - K992469

Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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510(K) Number K992469
Device Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
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 876.1500

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Classification Product Code FET
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Date Received 07/26/1999
Decision Date 10/15/1999
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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