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FDA 510(k) Application Details - K000039
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K000039
Device Name
Condom
Applicant
INDUS MEDICARE LTD.
144, S.P. RD., BEGUMPET
HYDERABAD ANDHRA PRADESH 500 016 IN
Other 510(k) Applications for this Company
Contact
P.K. REDDY
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
01/06/2000
Decision Date
03/21/2000
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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