HOSPAL BIOSPAL SCU/CAVH 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 Hospal Biospal Scu/cavh Kit.

Pre-market Notification Details

Device IDK841152
510k NumberK841152
Device Name:HOSPAL BIOSPAL SCU/CAVH KIT
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant HOSPAL MEDICAL CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-19
Decision Date1984-07-06

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