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FDA 510(k) Application Details - K132107
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K132107
Device Name
Condom
Applicant
NULATEX SDN. BHD.
LOT 1870, 4TH MILES JALAN
MENGKIBOL
KLUANG, JOHOR 86000 MY
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Contact
AI SIANG TEO
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
HIS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/08/2013
Decision Date
03/07/2014
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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