FILTRAL HEMODIALYZER

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 Hemodialyzer.

Pre-market Notification Details

Device IDK852885
510k NumberK852885
Device Name:FILTRAL HEMODIALYZER
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick,  NJ  08816
ContactDouglas L Vlchek
CorrespondentDouglas L Vlchek
HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick,  NJ  08816
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-09
Decision Date1985-09-06

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