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FDA 510(k) Application Details - K140304
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K140304
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
SIMPLY SOLUTIONS, LLC
2949 VENTURE DR., STE 170
JANESVILLE, WI 53546-8501 US
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Contact
JOHN GOEPFERT
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
02/07/2014
Decision Date
10/07/2014
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
Y
Expedited Review
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