Cleared Traditional

K954352 - BITE BLOCK (FDA 510(k) Clearance)

K954352 · United States Endoscopy Group, Inc. · Neurology device
Jan 1996
Decision
129d
Days
Class 2
Risk

K954352 is an FDA 510(k) clearance for the BITE BLOCK. This device is classified as a Block, Bite (Class II - Special Controls, product code JXL).

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on January 25, 1996, 129 days after receiving the submission on September 18, 1995.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5070.

Submission Details

510(k) Number K954352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date January 25, 1996
Days to Decision 129 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

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