FDA 510(k) Application Details - K962393

Device Classification Name Endoscope, Rigid

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510(K) Number K962393
Device Name Endoscope, Rigid
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
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 GCM
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Date Received 06/20/1996
Decision Date 09/17/1996
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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