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FDA 510(k) Application Details - K210095
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K210095
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
Thai Nippon Rubber Industry Public Company Limited
789/139 Pinthong Industrial Estate Nongkham
Sriracha 20230 TH
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Contact
Ryosuke Takamiya
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
NUC
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More FDA Info for this Product Code
Date Received
01/14/2021
Decision Date
11/23/2021
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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