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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 BK960066
Tradename Eagle Series Blood Storage Refrigerator # ST30RGBB and ST50
Device Name Refrigerator, Freezer, Blood Storage
Original Applicant
Frigidaire Commercial Products Company
707 robins st
conway,  AR  72032
Regulation Number864.9700
Classification Product Code
KSE  
Date Received08/19/1996
Decision Date 08/30/1996
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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