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FDA 510(k) Application Details - K012277
Device Classification Name
Pessary, Vaginal
More FDA Info for this Device
510(K) Number
K012277
Device Name
Pessary, Vaginal
Applicant
SIMS PORTEX LTD.
HYTHE
HYTHE, KENT CT 21 6JL GB
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Contact
STEVEN OGILVIE
Other 510(k) Applications for this Contact
Regulation Number
884.3575
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Classification Product Code
HHW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/19/2001
Decision Date
02/11/2002
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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