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FDA 510(k) Application Details - K121241
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K121241
Device Name
Condom
Applicant
NULATEX SDN. BHD.
LOT 1870, 4TH MLE
MENGKIBOL
KLUANG 86000 MY
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Contact
TEO AI SIANG
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
HIS
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More FDA Info for this Product Code
Date Received
04/25/2012
Decision Date
02/14/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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