SMD Sr90-1 Radionuclide Brachytherapy Source— 510(k) K142701

Name: FDA 510(k) clearance K142701
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Substantially Equivalent

Salutaris Medical Devices, Inc.

FDA 510(k) clearance K142701 for SMD Sr90-1 Radionuclide Brachytherapy Source, Substantially Equivalent on 2014-12-19. Applicant: Salutaris Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Salutaris Medical Devices, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2014-09-22
Decision date: 2014-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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