FDA 510(k) Application Details - K960810

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K960810
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant MARLO SURGICAL TECHNOLOGY
1810 JOSEPH LLOYD PKWY.
WILLOUGHBY, OH 44094 US
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Contact ARTHUR S GODDARD
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 02/28/1996
Decision Date 10/21/1996
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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