CHEMOTHERAPY INFUSION CATHETER

Catheter, Infusion

AMERICAN HEYER SCHULTE

The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for Chemotherapy Infusion Catheter.

Pre-market Notification Details

Device IDK822096
510k NumberK822096
Device Name:CHEMOTHERAPY INFUSION CATHETER
ClassificationCatheter, Infusion
Applicant AMERICAN HEYER SCHULTE 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJCY  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-07-16
Decision Date1983-04-12

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