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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 BK900032
Tradename MP III
Device Name Refrigerator, Freezer, Blood Storage
Original Applicant
Insta Cool, Inc of North America
11300 sanders drive, suite 14
rancho cordova,  CA  95742
Regulation Number864.9700
Classification Product Code
KSE  
Date Received11/01/1990
Decision Date 03/30/1992
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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