HEMODIALYZER, MODEL RP610, RP AN 69

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 Hemodialyzer, Model Rp610, Rp An 69.

Pre-market Notification Details

Device IDK781464
510k NumberK781464
Device Name:HEMODIALYZER, MODEL RP610, RP AN 69
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant HOSPAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-08-25
Decision Date1978-12-20

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