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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name refrigerator, freezer, blood storage
510(k) Number BK920006
Tradename CONTINENTAL REFRIG. BLD.BNK. MODEL C-BBRA-1S
Device Name Refrigerator, Freezer, Blood Storage
Original Applicant
Connaught Laboratories Limited
discovery drive
swiftwater,  PA  18370
Regulation Number864.9700
Classification Product Code
KSE  
Date Received03/02/1992
Decision Date 07/17/1992
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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