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FDA 510(k) Application Details - K150147
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K150147
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
UNIDERM FARMACEUTICI SRL
VIALE ENRICO ORTOLANI 211
ROMA 00125 IT
Other 510(k) Applications for this Company
Contact
Giorgio Chiozza
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
01/22/2015
Decision Date
02/19/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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