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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 K914053
Device Name SYSTEM 350
Original Applicant
420 alcott st.
kalamazoo,  MI  49001
Original Contact bertha erlenbush
Regulation Number868.5830
Classification Product Code
Date Received09/09/1991
Decision Date 09/25/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No