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FDA 510(k) Application Details - K994118
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K994118
Device Name
Condom
Applicant
GUILIN LATEX FACTORY
93 MORNINGSIDE DR.
SAN FRANCISCO, CA 94132 US
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Contact
PETER WEI
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Regulation Number
884.5300
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Classification Product Code
HIS
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More FDA Info for this Product Code
Date Received
12/06/1999
Decision Date
08/14/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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