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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, warming. blood and plasma
510(k) Number BK910011
Tradename MT-200 FROZEN PLASMA THAWER
Device Name Device, Warming, Blood and Plasma
Original Applicant
Insta Cool, Inc of North America
11300 sanders drive, suite 14
rancho cordova,  CA  95742
Regulation Number864.9205
Classification Product Code
KZL  
Date Received05/20/1991
Decision Date 12/19/1991
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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