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FDA 510(k) Application Details - K141256
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K141256
Device Name
Condom
Applicant
OKAMOTO U.S.A., INC.
700 THIRTEENTH STREET, N.W.
SUITE 1200
WASHINGTON, DC 20005 US
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Contact
JOSEPH W CORMIER, JD, PHD
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Regulation Number
884.5300
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Classification Product Code
HIS
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More FDA Info for this Product Code
Date Received
05/14/2014
Decision Date
07/23/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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