FDA 510(k) Application Details - K990004

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K990004
Device Name Laparoscope, Gynecologic (And Accessories)
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 884.1720

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Classification Product Code HET
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Date Received 01/04/1999
Decision Date 04/02/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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