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FDA 510(k) Application Details - K012935
Device Classification Name
Cannula, Intrauterine Insemination
More FDA Info for this Device
510(K) Number
K012935
Device Name
Cannula, Intrauterine Insemination
Applicant
SELECT MEDICAL SYSTEMS, INC.
P.O. BOX 966
WILLISTON, VT 05495-0966 US
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Contact
MONIQUE GIRARD
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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
08/31/2001
Decision Date
10/11/2001
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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