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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 K864374
Device Name ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM
Original Applicant
SHERWOOD MEDICAL CO.
1915 olive st.
st. louis,  MO  63103 1625
Original Contact frank s morrison
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/05/1986
Decision Date 03/16/1987
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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