Cleared Special

ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS

K133604 · The Anspach Effort, Inc. · Neurology
Jan 2014
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K133604 is an FDA 510(k) clearance for the ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS, 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 January 10, 2014, 46 days after receiving the submission on November 25, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number K133604 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2013
Decision Date January 10, 2014
Days to Decision 46 days
Submission Type Special
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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