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FDA 510(k) Application Details - K122476
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K122476
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
ANSELL HEALTHCARE PRODUCTS, LLC
4 LOS VERDES DRIVE
SAN LUIS OBISPO, CA 93401 US
Other 510(k) Applications for this Company
Contact
DONNA DI GANGI
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
08/14/2012
Decision Date
03/07/2013
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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