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FDA 510(k) Application Details - K222567
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K222567
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
Playground For All
4645 California Street
San Francisco, CA 94118 US
Other 510(k) Applications for this Company
Contact
Sandy Vukovic
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
08/24/2022
Decision Date
01/30/2023
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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