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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cord blood processing system and storage container
510(k) Number BK190356
Tradename PrepaCyte®-CB Processing System
Device Name Cord blood processing system and storage container
Original Applicant
Cryo-Cell International, Inc.
700 brooker creek blvd
oldsmar,  FL  34677
Regulation Number864.9900
Classification Product Code
OAO  
Date Received06/03/2019
Decision Date 06/17/2020
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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