MAGO 4S— 510(k) K093101

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K093101 for MAGO 4S, Substantially Equivalent on 2011-01-21. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 2009-10-01
Decision date: 2011-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.