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FDA 510(k) Application Details - K072169
Device Classification Name
Condom, Synthetic
More FDA Info for this Device
510(K) Number
K072169
Device Name
Condom, Synthetic
Applicant
SSL AMERICAS, INC.
3585 ENGINEERING DR.
SUITE 200
NORCROSS, GA 30092 US
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Contact
CHRIS ROBINSON
Other 510(k) Applications for this Contact
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
08/06/2007
Decision Date
06/19/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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