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FDA 510(k) Application Details - K132772
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K132772
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
UNIDERM FARMACEUTICI SRL
VIA A. ALTOBELLI BONETTI 3A
IMOLA, BO 40026 IT
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Contact
GUIDO BONAPACE
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
09/05/2013
Decision Date
08/22/2014
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
N
Expedited Review
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