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FDA 510(k) Application Details - K213921
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K213921
Device Name
Condom
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
HIS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2021
Decision Date
04/28/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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