FDA 510(k) Application Details - K020143

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K020143
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant GUIDANT CORPORATION, CARDIAC SURGERY
3200 LAKESIDE DR.
SANTA CLARA, CA 95054 US
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Contact ANNE SCHLAGENHAFT
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 01/16/2002
Decision Date 02/20/2002
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 Y
Expedited Review



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