THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200— 510(k) K010283

Name: FDA 510(k) clearance K010283
Creator: U.S. Food and Drug Administration
Published: 2001-04-26

Substantially Equivalent

Theragenics Corp.

FDA 510(k) clearance K010283 for THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200, Substantially Equivalent on 2001-04-26. 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: 2001-01-30
Decision date: 2001-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buford, GA, US

Download summary PDF View on FDA.gov ↗

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