TEFLON COATED GUIDE WIRES & CATHETER

Wire, Guide, Catheter

UNIVERSAL MEDICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Teflon Coated Guide Wires & Catheter.

Pre-market Notification Details

Device IDK822586
510k NumberK822586
Device Name:TEFLON COATED GUIDE WIRES & CATHETER
ClassificationWire, Guide, Catheter
Applicant UNIVERSAL MEDICAL INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-26
Decision Date1982-10-18

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