H1207

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 H1207.

Pre-market Notification Details

Device IDK830648
510k NumberK830648
Device Name:H1207
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 Received1983-03-01
Decision Date1983-03-29

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