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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 K120953
Models A-1500-08LF, S-100-08LF, S-1150-08LF
Device Name PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
Original Applicant
TLELFLEX MEDICAL, INC.
2917 weck drive
research triangle park,  NC  27709
Original Contact lorraine delong
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/30/2012
Decision Date 12/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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