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FDA 510(k) Application Details - K120287
Device Classification Name
Condom
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510(K) Number
K120287
Device Name
Condom
Applicant
CHURCH & DWIGHT CO., INC.
469 NORTH HARRISON STREET
PRINCETON, NJ 08543 US
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JOSEPH CICCONE
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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
01/31/2012
Decision Date
05/16/2012
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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