FDA 510(k) Application Details - K973909

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K973909
Device Name Laparoscope, General & Plastic Surgery
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 GCJ
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Date Received 10/14/1997
Decision Date 02/27/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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