OPEN ENDED URETERAL CATHETER

Catheter, Urethral

VAN-TEC, INC.

The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Open Ended Ureteral Catheter.

Pre-market Notification Details

Device IDK830840
510k NumberK830840
Device Name:OPEN ENDED URETERAL CATHETER
ClassificationCatheter, Urethral
Applicant VAN-TEC, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGBM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-16
Decision Date1983-04-06

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