PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST

Apparatus, Autotransfusion

PFIZER HOSPITAL PRODUCTS GROUP, INC.

The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Pleur-evac Plus Contin. Reinfus. & Autoinfus. Syst.

Pre-market Notification Details

Device IDK911656
510k NumberK911656
Device Name:PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST
ClassificationApparatus, Autotransfusion
Applicant PFIZER HOSPITAL PRODUCTS GROUP, INC. 600 AIRPORT RD. Fall River,  MA  02722
ContactMicheal Santalucia
CorrespondentMicheal Santalucia
PFIZER HOSPITAL PRODUCTS GROUP, INC. 600 AIRPORT RD. Fall River,  MA  02722
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-12
Decision Date1991-08-13

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