SOMATICS MOUTH GUARD (BITE BLOCK)— 510(k) K864181

Name: FDA 510(k) clearance K864181
Creator: U.S. Food and Drug Administration
Published: 1986-11-03

Substantially Equivalent

Somatics, Inc.

FDA 510(k) clearance K864181 for SOMATICS MOUTH GUARD (BITE BLOCK), Substantially Equivalent on 1986-11-03. Applicant: Somatics, Inc.. Device class: 2.

Clearance details

Applicant: Somatics, Inc.
Product code: Code JXL
Device class: Class 2
Regulation: 21 CFR 882.5070
Advisory panel: Neurology
Date received: 1986-10-27
Decision date: 1986-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Bluff, IL, US

Download summary PDF View on FDA.gov ↗

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