MICROSELECTRON-HDR (HIGH DOSE RATE)— 510(k) K864210

Name: FDA 510(k) clearance K864210
Creator: U.S. Food and Drug Administration
Published: 1986-11-26

Substantially Equivalent

Nucletron-Oldelft Corp.

FDA 510(k) clearance K864210 for MICROSELECTRON-HDR (HIGH DOSE RATE), Substantially Equivalent on 1986-11-26. Applicant: Nucletron-Oldelft Corp.. Device class: 2.

Clearance details

Applicant: Nucletron-Oldelft Corp.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 1986-10-28
Decision date: 1986-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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