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FDA 510(k) Application Details - K011363
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K011363
Device Name
Condom
Applicant
MARKETING SALES CONCEPTS, INC. (MSCI)
200 RENAISSANCE COMPANY
SUITE 111
ATLANTA, GA 30308 US
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Contact
ERIC J ARTHUR
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
HIS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/03/2001
Decision Date
03/25/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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