I-125 SEEDS, CODE: 6711— 510(k) K914281

Name: FDA 510(k) clearance K914281
Creator: U.S. Food and Drug Administration
Published: 1991-11-22

Substantially Equivalent

Medi-Physics Inc. Dba Nycomed Amersham Imaging

FDA 510(k) clearance K914281 for I-125 SEEDS, CODE: 6711, Substantially Equivalent on 1991-11-22. 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: 1991-09-24
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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