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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 BK930002
Tradename NSBR61 (Nor-Lake Scientific Blood Bank, 6ft Single Door)
Device Name Refrigerator, Freezer, Blood Storage
Original Applicant
Nor-Lake, Inc.
second and elm str. p.o. box 248
hudson,  WI  54016
Regulation Number864.9700
Classification Product Code
KSE  
Date Received03/04/1993
Decision Date 04/13/1995
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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