Cleared Traditional

TRITON HUDSON CHUCK ATTACHMENT

K983092 · Mednext, Inc. · Neurology
Nov 1998
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K983092 is an FDA 510(k) clearance for the TRITON HUDSON CHUCK ATTACHMENT, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Mednext, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on November 6, 1998, 64 days after receiving the submission on September 3, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K983092 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1998
Decision Date November 06, 1998
Days to Decision 64 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HBB — Motor, Drill, Pneumatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4370

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