CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT

Dialyzer, High Permeability With Or Without Sealed Dialysate System

HOSPAL MEDICAL CORP.

The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Cardioflow 100 Hemoconcentrator/preparation Kit.

Pre-market Notification Details

Device IDK883307
510k NumberK883307
Device Name:CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant HOSPAL MEDICAL CORP. 21 NORTHFIELD AVE. RARITAN CENTER Edison,  NJ  08837
ContactCatherina Madormo
CorrespondentCatherina Madormo
HOSPAL MEDICAL CORP. 21 NORTHFIELD AVE. RARITAN CENTER Edison,  NJ  08837
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-04
Decision Date1988-10-12

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