Cleared Traditional

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY

K954717 · Sodem Diffusion SA · Neurology
Jan 1997
Decision
467d
Days
Class 2
Risk

About This 510(k) Submission

K954717 is an FDA 510(k) clearance for the SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Sodem Diffusion SA (North Attleboro, US). The FDA issued a Cleared decision on January 22, 1997, 467 days after receiving the submission on October 13, 1995. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K954717 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 1995
Decision Date January 22, 1997
Days to Decision 467 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBB — Motor, Drill, Pneumatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4370

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