I-125 RAPID STRAND— 510(k) K940632

Name: FDA 510(k) clearance K940632
Creator: U.S. Food and Drug Administration
Published: 1994-09-02

Substantially Equivalent

Medi-Physics Inc. Dba Nycomed Amersham Imaging

FDA 510(k) clearance K940632 for I-125 RAPID STRAND, Substantially Equivalent on 1994-09-02. Applicant: Medi-Physics Inc. Dba Nycomed Amersham Imaging. Device class: 2.

Clearance details

Applicant: Medi-Physics Inc. Dba Nycomed Amersham Imaging
Product code: Code IWI
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1994-02-14
Decision date: 1994-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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