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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K232279
Device Name LifeStyles NRL Textured Condom
Applicant
Suretex Limited
31/1 Moo 4, Suratthani-Thakuapha Rd.
Tambon Khao Kwai, Amphur Phunphin,  TH 84130
Applicant Contact Alison Arnot
Correspondent
Digangi Consulting, LLC
708 Firethorn Lane
Round Rock,  TX  78664
Correspondent Contact Donna DiGangi
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/31/2023
Decision Date 10/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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