.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR— 510(k) K040804

Name: FDA 510(k) clearance K040804
Creator: U.S. Food and Drug Administration
Published: 2004-04-28

Substantially Equivalent

Southeastern Radiation Products, Inc.

FDA 510(k) clearance K040804 for .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR, Substantially Equivalent on 2004-04-28. Applicant: Southeastern Radiation Products, Inc.. Device class: 2.

Clearance details

Applicant: Southeastern Radiation Products, Inc.
Product code: Code IXI
Device class: Class 2
Regulation: 21 CFR 892.5710
Advisory panel: Radiology
Date received: 2004-03-29
Decision date: 2004-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sanford, FL, US

Download summary PDF View on FDA.gov ↗

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