I-125 SEEDS CODE: 6702— 510(k) K915156

Name: FDA 510(k) clearance K915156
Creator: U.S. Food and Drug Administration
Published: 1992-01-06

Substantially Equivalent

Medi-Physics Inc. Dba Nycomed Amersham Imaging

FDA 510(k) clearance K915156 for I-125 SEEDS CODE: 6702, Substantially Equivalent on 1992-01-06. Applicant: Medi-Physics Inc. Dba Nycomed Amersham Imaging. Device class: 2.

Clearance details

Applicant: Medi-Physics Inc. Dba Nycomed Amersham Imaging
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1991-11-14
Decision date: 1992-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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