AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR

Filter, Infusion Line

PALL BIOMEDICAL PRODUCTS CO.

The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Aef Posidyne I.v. Filter/air Eliminator.

Pre-market Notification Details

Device IDK850825
510k NumberK850825
Device Name:AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR
ClassificationFilter, Infusion Line
Applicant PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove,  NY  11542
ContactSidney Krakauer
CorrespondentSidney Krakauer
PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove,  NY  11542
Product CodeFPB  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-28
Decision Date1985-04-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30636207301193 K850825 000
30636207300936 K850825 000
30636207300905 K850825 000
30636207000348 K850825 000
30636207000331 K850825 000
30636207000324 K850825 000
30636207000126 K850825 000

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