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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K242107
Device Name CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)
Applicant
Casebioscience, Inc.
24 Norwich St. E.
Guelph,  CA N1H2G6
Applicant Contact Monica Mezezi
Correspondent
Casebioscience, Inc.
24 Norwich St. E.
Guelph,  CA N1H2G6
Correspondent Contact Monica Mezezi
Regulation Number884.6180
Classification Product Code
MQL  
Date Received07/18/2024
Decision Date 03/21/2025
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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