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FDA 510(k) Application Details - K020272
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K020272
Device Name
Condom
Applicant
PLEASURE LATEX PRODUCTS SDN. BHD.
LOT 1365, 17TH MILES, JALAN
SUNGAI SEMBILANG
JERAM, SELANGOR DARUL EHSAN 45800 MY
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Contact
KOI-YONG LIM
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
01/28/2002
Decision Date
04/26/2002
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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