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FDA 510(k) Application Details - K223519
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K223519
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
Karex Industries Sdn. Bhd.
PTD 7906 & 7907, Taman Pontian Jaya
Bt. 34, Jalan Johor
Pontian 82000 MY
Other 510(k) Applications for this Company
Contact
Lai Peng Lim
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
11/23/2022
Decision Date
08/11/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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