I-SEED— 510(k) K103319

Substantially Equivalent

Theragenics Corp.

FDA 510(k) clearance K103319 for I-SEED, Substantially Equivalent on 2011-01-03. Applicant: Theragenics Corp..

Clearance details

Applicant: Theragenics Corp.
Product code: Code KXK
Advisory panel: Radiology
Date received: 2010-11-12
Decision date: 2011-01-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buford, GA, US

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