FILTRAL TM 20 HEMODIALYZER/FILTER

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 Filtral Tm 20 Hemodialyzer/filter.

Pre-market Notification Details

Device IDK893742
510k NumberK893742
Device Name:FILTRAL TM 20 HEMODIALYZER/FILTER
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant HOSPAL MEDICAL CORP. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg,  VA  23185
ContactJo Lang
CorrespondentJo Lang
HOSPAL MEDICAL CORP. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg,  VA  23185
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-17
Decision Date1989-07-24

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