Cleared Traditional

TruGuard Custom Tongue and Jaw Positioner

K153270 · Bionix Development Corp. · Radiology
Mar 2016
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K153270 is an FDA 510(k) clearance for the TruGuard Custom Tongue and Jaw Positioner, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Bionix Development Corp. (Toledo, US). The FDA issued a Cleared decision on March 8, 2016, 117 days after receiving the submission on November 12, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K153270 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2015
Decision Date March 08, 2016
Days to Decision 117 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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