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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 K942791
Device Name ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT
Original Applicant
SHERWOOD MEDICAL CO.
1915 olive st.
st. louis,  MO  63103 1642
Original Contact dennis pozzo
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/14/1994
Decision Date 05/10/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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