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FDA 510(k) Application Details - K071626
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K071626
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
SSL AMERICAS
3583 ENGINEERING DR. SUITE 200
NORCROSS, GA 30092 US
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Contact
CHRIS ROBINSON
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
06/14/2007
Decision Date
04/01/2008
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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