Cleared Traditional

ANSPACH EMAX DRILL SYSTEM

K011444 · The Anspach Effort, Inc. · Neurology
Aug 2001
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K011444 is an FDA 510(k) clearance for the ANSPACH EMAX DRILL SYSTEM, a Motor, Drill, Electric (Class II — Special Controls, product code HBC), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on August 8, 2001, 89 days after receiving the submission on May 11, 2001. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number K011444 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2001
Decision Date August 08, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBC — Motor, Drill, Electric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4360

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