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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, autotransfusion
510(k) Number K904515
Device Name IMPRAFLO 3500 SERIES
Original Applicant
1625 west 3rd st.
p.o. box 1740
tempe,  AZ  85281
Original Contact janine phodes
Regulation Number868.5830
Classification Product Code
Date Received10/03/1990
Decision Date 12/04/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No