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FDA 510(k) Application Details - K990669
Device Classification Name
Condom With Nonoxynol-9
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510(K) Number
K990669
Device Name
Condom With Nonoxynol-9
Applicant
DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD.
7TH FL. MAYBAN TRUST BLDG.
3 PENANG ST.
PENANG 10200 MY
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Contact
PETER PARK
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Regulation Number
884.5310
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Classification Product Code
LTZ
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More FDA Info for this Product Code
Date Received
03/02/1999
Decision Date
05/17/1999
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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