Cleared Traditional

HAND DRILL, MODEL 11-9901-7

K022712 · Medical Design, LLC · Neurology
Nov 2002
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K022712 is an FDA 510(k) clearance for the HAND DRILL, MODEL 11-9901-7, a Drills, Burrs, Trephines & Accessories (manual) (Class II — Special Controls, product code HBG), submitted by Medical Design, LLC (Brandon, US). The FDA issued a Cleared decision on November 12, 2002, 90 days after receiving the submission on August 14, 2002. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4300.

Submission Details

510(k) Number K022712 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2002
Decision Date November 12, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBG — Drills, Burrs, Trephines & Accessories (manual)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4300

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