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FDA 510(k) Application Details - K964848
Device Classification Name
Cannula, Intrauterine Insemination
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510(K) Number
K964848
Device Name
Cannula, Intrauterine Insemination
Applicant
MARLOW SURGICAL TECHNOLOGIES, INC.
1810 JOSEPH LLOYD PKWY.
WILLOUGHBY, OH 44094 US
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Contact
ARTHUR S GODDARD
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Regulation Number
884.5250
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Classification Product Code
MFD
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More FDA Info for this Product Code
Date Received
12/03/1996
Decision Date
01/16/1997
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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