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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 BK900017
Tradename Solid State Portable Refrigerator
Device Name Refrigerator, Freezer, Blood Storage
Original Applicant
Thermopol Inc.
2481 b delta ln,
elk grove village,  IL  60007
Regulation Number864.9700
Classification Product Code
KSE  
Date Received05/15/1990
Decision Date 08/30/1990
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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