Cleared Traditional

ANSPACH ANGLED MICRONOSE ATTACHMENT

K002903 · The Anspach Effort, Inc. · Neurology
Oct 2000
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K002903 is an FDA 510(k) clearance for the ANSPACH ANGLED MICRONOSE ATTACHMENT, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on October 24, 2000, 36 days after receiving the submission on September 18, 2000. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K002903 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2000
Decision Date October 24, 2000
Days to Decision 36 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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