PALL EC PLUS FILTER W/FILTER SLEEVE

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

PALL BIOMEDICAL PRODUCTS CO.

The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Ec Plus Filter W/filter Sleeve.

Pre-market Notification Details

Device IDK834382
510k NumberK834382
Device Name:PALL EC PLUS FILTER W/FILTER SLEEVE
ClassificationFilter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant PALL BIOMEDICAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDTM  
CFR Regulation Number870.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-14
Decision Date1984-08-03

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