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FDA 510(k) Application Details - K013433
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K013433
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
ARMKEL LLC
P.O. BOX 1001 HALF ACRE RD.
CRANBURY,, NJ 08512 US
Other 510(k) Applications for this Company
Contact
STEPHEN C KOLAKOWSKY
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
10/16/2001
Decision Date
03/05/2002
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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