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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Cervical
510(k) Number K242031
Device Name Béa Applicator (BAP-GB-01)
Applicant
Stepone Fertility Ltd (T/A Béa Fertility)
71-75 Shelton St.
Covent Garden
London,  GB WC2H 9JQ
Applicant Contact Tom Littleford
Correspondent
Stepone Fertility Ltd (T/A Béa Fertility)
71-75 Shelton St.
Covent Garden
London,  GB WC2H 9JQ
Correspondent Contact Tom Littleford
Regulation Number884.5250
Classification Product Code
HDR  
Subsequent Product Codes
FMH   OBB  
Date Received07/11/2024
Decision Date 04/02/2025
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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