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FDA 510(k) Application Details - K181078
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
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510(K) Number
K181078
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
Necessaire, Inc.
10 Arbolo Court
Manhattan Beach, CA 90266 US
Other 510(k) Applications for this Company
Contact
Randi Christiansen Stanley
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
04/24/2018
Decision Date
09/10/2018
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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