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FDA 510(k) Application Details - K124044
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K124044
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
SEVEN OAKS RANCH, INC.
2658 CHANNEL DRIVE
VENTURA, CA 93003 US
Other 510(k) Applications for this Company
Contact
Calley Herzog
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
NUC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/31/2012
Decision Date
08/30/2013
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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