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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name refrigerator, freezer, blood storage
510(k) Number BK960072
Tradename CryoSeal System
Device Name Refrigerator, Freezer, Blood Storage
Original Applicant
Thermogenesis
3146 gold camp drive
suite 206
rancho cordova,  CA  95670 6022
Regulation Number864.9700
Classification Product Code
KSE  
Date Received09/13/1996
Decision Date 02/12/1999
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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