Cleared Traditional

MEDNEXT MICRO-DRILL

K943108 · Mednext, Inc. · Ear, Nose, Throat

Aug 1994

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K943108 is an FDA 510(k) clearance for the MEDNEXT MICRO-DRILL, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Mednext, Inc. (Riviera Beach, US). The FDA issued a Cleared decision on August 17, 1994, 49 days after receiving the submission on June 29, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K943108 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 1994
Decision Date	August 17, 1994
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4250