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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 K851024
Device Name PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE
Applicant
PFIZER, INC.
235 E 42ND ST.
NY,  NY  10017
Applicant Contact SHELDON STEINBERG
Correspondent
PFIZER, INC.
235 E 42ND ST.
NY,  NY  10017
Correspondent Contact SHELDON STEINBERG
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/12/1985
Decision Date 05/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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