Cleared Traditional

BITE STICK, DYNA

K760258 · Dyna-Med · Neurology
Jul 1976
Decision
6d
Days
Class 2
Risk

About This 510(k) Submission

K760258 is an FDA 510(k) clearance for the BITE STICK, DYNA, a Block, Bite (Class II — Special Controls, product code JXL), submitted by Dyna-Med (Mchenry, US). The FDA issued a Cleared decision on July 26, 1976, 6 days after receiving the submission on July 20, 1976. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5070.

Submission Details

510(k) Number K760258 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1976
Decision Date July 26, 1976
Days to Decision 6 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code JXL — Block, Bite
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5070

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