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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, processing for frozen blood
510(k) Number DK760914
Tradename Double Elutra-Pack Unit, Code 4R2402
Device Name Processing Systems for Frozen Blood
Original Applicant
Travenol Laboratories
rt 120 and wilson rd.
round lake,  IL  60073
Regulation Number864.9145
Classification Product Code
Date Received10/27/1976
Decision Date 11/22/1976
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