FMA TRANSLATOR— 510(k) K912086

Substantially Equivalent

Normandie Group, Inc.

FDA 510(k) clearance K912086 for FMA TRANSLATOR, Substantially Equivalent on 1991-08-07. Applicant: Normandie Group, Inc.. Device class: 1.

Clearance details

Applicant: Normandie Group, Inc.
Product code: Code BXB
Device class: Class 1
Regulation: 21 CFR 890.5380
Advisory panel: Physical Medicine
Date received: 1991-05-13
Decision date: 1991-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montgomery, AL, 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.