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FDA 510(k) Application Details - K210986
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K210986
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
CC Wellness LLC
29000 N. Hancock Pkwy.
Valencia, CA 91355 US
Other 510(k) Applications for this Company
Contact
Marlent Perez
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
04/01/2021
Decision Date
06/10/2021
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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