FDA 510(k) Application Details - K960640

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K960640
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
8305 MELROSE DR.
LENEXA, KS 66214 US
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Contact JAY SULLIVAN
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 02/12/1996
Decision Date 02/14/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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