IMAGER, BODY SECTION, RADIONUCLIDE— 510(k) K780395

Name: FDA 510(k) clearance K780395
Creator: U.S. Food and Drug Administration
Published: 1978-03-31

Substantially Equivalent

Union Carbide Corp.

FDA 510(k) clearance K780395 for IMAGER, BODY SECTION, RADIONUCLIDE, Substantially Equivalent on 1978-03-31. Applicant: Union Carbide Corp.. Device class: 1.

Clearance details

Applicant: Union Carbide Corp.
Product code: Code IYW
Device class: Class 1
Regulation: 21 CFR 892.1300
Advisory panel: Radiology
Date received: 1978-03-13
Decision date: 1978-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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