FDA 510(k) Application Details - K942389

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K942389
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact HOWARD M HOLSTEIN
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 05/18/1994
Decision Date 02/16/1996
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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