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FDA 510(k) Application Details - K152918
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K152918
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
EMPOWERED PRODUCTS, INC.
3367 W. OQUENDO RD.
LAS VEGAS, NV 89118 US
Other 510(k) Applications for this Company
Contact
MATT CARR
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
10/02/2015
Decision Date
06/02/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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