Macroduct Advanced Model 3710— 510(k) K180627

Name: FDA 510(k) clearance K180627
Creator: U.S. Food and Drug Administration
Published: 2018-07-27

Substantially Equivalent

Elitechgroup, Inc.

FDA 510(k) clearance K180627 for Macroduct Advanced Model 3710, Substantially Equivalent on 2018-07-27. Applicant: Elitechgroup, Inc.. Device class: 2.

Clearance details

Applicant: Elitechgroup, Inc.
Product code: Code KTB
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 2018-03-09
Decision date: 2018-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Logan, UT, US

Download summary PDF View on FDA.gov ↗

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