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FDA 510(k) Application Details - K171639
Device Classification Name
Condom, Synthetic
More FDA Info for this Device
510(K) Number
K171639
Device Name
Condom, Synthetic
Applicant
Church & Dwight Co., Inc.
500 Charles Ewing Blvd.
Ewing, NJ 08628 US
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Contact
Lisa Burns
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Regulation Number
884.5300
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Classification Product Code
MOL
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More FDA Info for this Product Code
Date Received
06/02/2017
Decision Date
08/01/2017
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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