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FDA 510(k) Application Details - K113061
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K113061
Device Name
Condom
Applicant
KAREX INDUSTRIES SDN BHD.
PTD. 7906 & 7907, TAMAN
PONTIAN JAYA, BT 34
JOHOR DARUL TAKZIM 82000 MY
Other 510(k) Applications for this Company
Contact
LAI PENG
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
10/14/2011
Decision Date
12/07/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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