PCI W/CATH-SEAL SIDE FLOW FITTING

Introducer, Catheter

UNIVERSAL MEDICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Pci W/cath-seal Side Flow Fitting.

Pre-market Notification Details

Device IDK842259
510k NumberK842259
Device Name:PCI W/CATH-SEAL SIDE FLOW FITTING
ClassificationIntroducer, Catheter
Applicant UNIVERSAL MEDICAL INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-07
Decision Date1984-08-01

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