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FDA 510(k) Application Details - K150828
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K150828
Device Name
Condom
Applicant
O-RING Products LLC
4012 Grand Manor Court, #208
Raleigh, NC 27612 US
Other 510(k) Applications for this Company
Contact
William Mistler
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
03/30/2015
Decision Date
12/18/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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