MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE— 510(k) K013875

Name: FDA 510(k) clearance K013875
Creator: U.S. Food and Drug Administration
Published: 2002-09-27

Substantially Equivalent

Med-Tec,Inc.

FDA 510(k) clearance K013875 for MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE, Substantially Equivalent on 2002-09-27. Applicant: Med-Tec,Inc.. Device class: 2.

Clearance details

Applicant: Med-Tec,Inc.
Product code: Code IXI
Device class: Class 2
Regulation: 21 CFR 892.5710
Advisory panel: Radiology
Date received: 2001-11-23
Decision date: 2002-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange City, IA, US

Download summary PDF View on FDA.gov ↗

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