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FDA 510(k) Application Details - K042957
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K042957
Device Name
Condom
Applicant
SSL AMERICAS
3583 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
More FDA Info for this Regulation Number
Classification Product Code
HIS
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More FDA Info for this Product Code
Date Received
10/27/2004
Decision Date
02/17/2005
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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