Cleared Traditional

K002903 - ANSPACH ANGLED MICRONOSE ATTACHMENT (FDA 510(k) Clearance)

K002903 · The Anspach Effort, Inc. · Neurology device

Oct 2000

Decision

36d

Days

Class 2

Risk

K002903 is an FDA 510(k) clearance for the ANSPACH ANGLED MICRONOSE ATTACHMENT. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K002903 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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