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FDA 510(k) Application Details - K012964
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K012964
Device Name
Condom
Applicant
INNOLATEX SDN. BHD
NO. 16, JALAN BULAN U5/5,
BANDAR PINGGIRAN SUBANG
SHAH ALAM, SELANGOR D.E. 40150 MY
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Contact
CHANG AH-KAU
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
09/04/2001
Decision Date
11/09/2001
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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