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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 K911656
Device Name PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST
Applicant
Pfizer Hospital Products Group, Inc.
600 Airport Rd.
Fall River,  MA  02722
Applicant Contact MICHEAL SANTALUCIA
Correspondent
Pfizer Hospital Products Group, Inc.
600 Airport Rd.
Fall River,  MA  02722
Correspondent Contact MICHEAL SANTALUCIA
Regulation Number868.5830
Classification Product Code
CAC  
Date Received04/12/1991
Decision Date 08/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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