GOLD(AU 195) SPOT MARKER SOURCES— 510(k) K812235

Name: FDA 510(k) clearance K812235
Creator: U.S. Food and Drug Administration
Published: 1981-09-09

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K812235 for GOLD(AU 195) SPOT MARKER SOURCES, Substantially Equivalent on 1981-09-09. Applicant: Amersham Corp.. Device class: 1.

Clearance details

Applicant: Amersham Corp.
Product code: Code IXD
Device class: Class 1
Regulation: 21 CFR 892.1400
Advisory panel: Radiology
Date received: 1981-08-11
Decision date: 1981-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.