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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 BK950066
Tradename Revco HLT 30V-4BB
Device Name Refrigerator, Freezer, Blood Storage
Original Applicant
Revco/Lindberg
275 aiken road
asheville,  NC  28804
Regulation Number864.9700
Classification Product Code
KSE  
Date Received11/13/1995
Decision Date 01/31/1996
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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