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FDA 510(k) Application Details - K221243
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K221243
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
Suretex Limited
31/1 Moo 4, Suratthani-Thakuapha Road
Tambon Khao Hua Kwai, Amphur Phunphin 84130 TH
Other 510(k) Applications for this Company
Contact
KC Nguyen
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
05/02/2022
Decision Date
09/30/2022
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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