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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 BK890006
Tradename MBF 500 Blood Freezer
Device Name Refrigerator, Freezer, Blood Storage
Original Applicant
Rexco
275 aiken
asheville,  NC  28804
Regulation Number864.9700
Classification Product Code
KSE  
Date Received02/24/1989
Decision Date 06/16/1989
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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