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FDA 510(k) Application Details - K092586
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K092586
Device Name
Condom
Applicant
INNOLATEX (THAILAND) LIMITED
SOUTHERN INDUSTRIAL ESTATE
VILLAGE 4 CHALUNG SUB-DISTRICT
HATYAI DISTRICT, SONGKHLA 90110 TH
Other 510(k) Applications for this Company
Contact
GOH SAING
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
08/24/2009
Decision Date
05/12/2010
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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