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FDA 510(k) Application Details - K192204
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K192204
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
Valencia Naturals Inc.
9731 Topanga Canyon PL.
Chatsworth, CA 91311 US
Other 510(k) Applications for this Company
Contact
Louie Goryoka
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
NUC
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More FDA Info for this Product Code
Date Received
08/14/2019
Decision Date
11/19/2019
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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