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FDA 510(k) Application Details - K070937
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K070937
Device Name
Condom
Applicant
NULATEX SDN. BHD.
LOT 1870, 4TH MILES JALAN
MENGKIBOL
KLUANG, JOHOR 86000 MY
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Contact
KIM L LEE
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
04/04/2007
Decision Date
09/21/2007
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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