Cleared Special

MICROPOWER HAND PIECE HIGH SPEED DRILL

K060260 · Linvatec Corp. · Neurology
Apr 2006
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K060260 is an FDA 510(k) clearance for the MICROPOWER HAND PIECE HIGH SPEED DRILL, a Motor, Drill, Electric (Class II — Special Controls, product code HBC), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on April 10, 2006, 68 days after receiving the submission on February 1, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number K060260 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2006
Decision Date April 10, 2006
Days to Decision 68 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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