AMERITEK SURE-POINT HDR NEEDLE TEMPLATE— 510(k) K031273

Name: FDA 510(k) clearance K031273
Creator: U.S. Food and Drug Administration
Published: 2003-07-15

Substantially Equivalent

Amertek Medical, Inc.

FDA 510(k) clearance K031273 for AMERITEK SURE-POINT HDR NEEDLE TEMPLATE, Substantially Equivalent on 2003-07-15. Applicant: Amertek Medical, Inc.. Device class: 2.

Clearance details

Applicant: Amertek Medical, Inc.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2003-04-22
Decision date: 2003-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singer Island, FL, US

Download summary PDF View on FDA.gov ↗

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