MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY— 510(k) K011493

Name: FDA 510(k) clearance K011493
Creator: U.S. Food and Drug Administration
Published: 2002-10-01

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K011493 for MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY, Substantially Equivalent on 2002-10-01. Applicant: Mentor Corp.. Device class: 2.

Clearance details

Applicant: Mentor Corp.
Product code: Code KPT
Device class: Class 2
Regulation: 21 CFR 892.1360
Advisory panel: Radiology
Date received: 2001-05-15
Decision date: 2002-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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