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FDA 510(k) Application Details - K130012
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K130012
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
TRIGG LABORATORIES, INC.
28650 Braxton Ave
Valencia, CA 91355 US
Other 510(k) Applications for this Company
Contact
ERNIE JOHNSON
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
01/02/2013
Decision Date
08/22/2013
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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