POIINT OF CARE STRANDING SYSTEM, MODE 1004-00— 510(k) K072296

Name: FDA 510(k) clearance K072296
Creator: U.S. Food and Drug Administration
Published: 2007-09-26

Substantially Equivalent

Theragenics Corp.

FDA 510(k) clearance K072296 for POIINT OF CARE STRANDING SYSTEM, MODE 1004-00, Substantially Equivalent on 2007-09-26. Applicant: Theragenics Corp.. Device class: 2.

Clearance details

Applicant: Theragenics Corp.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2007-08-17
Decision date: 2007-09-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buford, GA, US

Download summary PDF View on FDA.gov ↗

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