ECHOSEED/IODINE-125 SEEDS, MODEL 6733— 510(k) K010821

Name: FDA 510(k) clearance K010821
Creator: U.S. Food and Drug Administration
Published: 2001-04-11

Substantially Equivalent

Medi-Physics Inc. Dba Nycomed Amersham Imaging

FDA 510(k) clearance K010821 for ECHOSEED/IODINE-125 SEEDS, MODEL 6733, Substantially Equivalent on 2001-04-11. 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: 2001-03-19
Decision date: 2001-04-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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