510(k) K232279

Device
LifeStyles NRL Textured Condom
Applicant
Suretex Limited
510(k) number
K232279
Product code
HIS
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-05
Date received
2023-07-31
Regulation
884.5300
Classification name
Condom
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alison Arnot
Address
31/1 Moo 4, Suratthani-Thakuapha Rd. Tambon Khao Kwai, Amphur Phunphin TH 84130 84130

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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