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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K250488
Device Name Cerynë Intimate Care
Applicant
Ansella Therapeutics
20602 Behrens Pass Lane
Cypress,  TX  77433
Applicant Contact Maria Carrasco
Correspondent
Ansella Therapeutics
20602 Behrens Pass Lane
Cypress,  TX  77433
Correspondent Contact Maria Carrasco
Regulation Number884.5300
Classification Product Code
NUC  
Date Received02/19/2025
Decision Date 12/12/2025
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 Yes
Predetermined Change
Control Plan Authorized		 No
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