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FDA 510(k) Application Details - K150883
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K150883
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
FIDIA FARMACEUTICI SPA
VIA PONTE DELLA FABBRICA 3/A
ABANO TERME 35031 IT
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Contact
Dr. Giuseppina Lo Castro
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
04/02/2015
Decision Date
09/01/2015
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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