Cleared Traditional

ANSPACH MICROMAX SYSTEM

K965080 · The Anspach Effort, Inc. · Ear, Nose, Throat

Jan 1997

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K965080 is an FDA 510(k) clearance for the ANSPACH MICROMAX SYSTEM, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 10, 1997, 22 days after receiving the submission on December 19, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K965080 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 1996
Decision Date	January 10, 1997
Days to Decision	22 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