FDA 510(k) Application Details - K021776

Device Classification Name Endoscopic Irrigation/Suction System

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510(K) Number K021776
Device Name Endoscopic Irrigation/Suction System
Applicant KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact JAMES A LEE
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Regulation Number 876.1500

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Classification Product Code OCX
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Date Received 05/29/2002
Decision Date 08/15/2002
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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