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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K231908
Device Name 45 Micron Polyisoprene Condom
Applicant
Suretex Limited
31/1 Moo 4, Suratthani-Thakuapha Rd.
Tambon Khao Kwai, Amphur Phunphin,  TH 84130
Applicant Contact Alison Arnot
Correspondent
C3-Carey Consultants, LLC
9451 Ellsworth Court
Fulton,  MD  20759
Correspondent Contact Carole C. Carey
Regulation Number884.5300
Classification Product Code
MOL  
Date Received06/29/2023
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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