HEYER-SCHULTE AFTERLOADING CATHETER— 510(k) K832738

Name: FDA 510(k) clearance K832738
Creator: U.S. Food and Drug Administration
Published: 1983-09-29

Substantially Equivalent

American Heyer Schulte

FDA 510(k) clearance K832738 for HEYER-SCHULTE AFTERLOADING CATHETER, Substantially Equivalent on 1983-09-29. Applicant: American Heyer Schulte. Device class: 1.

Clearance details

Applicant: American Heyer Schulte
Product code: Code IWJ
Device class: Class 1
Regulation: 21 CFR 892.5650
Advisory panel: Radiology
Date received: 1983-08-12
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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