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FDA 510(k) Application Details - K171730
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K171730
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
Non-Friction Products Inc.
551 Church Street
Toronto M4Y 2E2 CA
Other 510(k) Applications for this Company
Contact
Marc Barrette
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
06/12/2017
Decision Date
09/07/2017
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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