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FDA 510(k) Application Details - K040185
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K040185
Device Name
Condom
Applicant
SSL AMERICAS
3585 ENGINEERING DR.
NORCROSS, GA 30092 US
Other 510(k) Applications for this Company
Contact
KATHLEEN J HARRIS
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
01/27/2004
Decision Date
04/27/2004
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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