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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Culture, Ex Vivo, Tissue And Cell
510(k) Number K231804
Device Name PRIME-XV FreezIS DMSO-Free MD
Applicant
Fujifilm Irvine Scientific
1830 E. Warner Ave.
Santa Ana,  CA  92705
Applicant Contact Amanda Cinquin
Correspondent
Fujifilm Irvine Scientific
1830 E. Warner Ave.
Santa Ana,  CA  92705
Correspondent Contact Amanda Cinquin
Regulation Number876.5885
Classification Product Code
NDS  
Date Received06/20/2023
Decision Date 11/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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