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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 BK010045
Tradename Sahara Blood & Plasma Warming Device
Device Name Device, Warming, Blood and Plasma
Original Applicant
Sarstedt, Inc.
1025 saint james church rd.
newton,  NC  20865
Regulation Number864.9205
Classification Product Code
KZL  
Date Received10/29/2001
Decision Date 12/21/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
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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