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FDA 510(k) Application Details - K150857
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K150857
Device Name
Condom
Applicant
HANKOOK LATEX GONGUP CO., LTD.
61, SAKJU-RO 145BEON-GIL
CHUNCHEON-SI 200-060 KR
Other 510(k) Applications for this Company
Contact
KWON DUKEE
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
03/31/2015
Decision Date
08/14/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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