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FDA 510(k) Application Details - K150072
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K150072
Device Name
Condom
Applicant
THEYFIT
4140 TATE STREET
COVINGTON, GA 30014 US
Other 510(k) Applications for this Company
Contact
MICHAEL CECIL
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
01/14/2015
Decision Date
04/14/2015
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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