About This 510(k) Submission
K955174 is an FDA 510(k) clearance for the SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY, a Motor, Surgical Instrument, Pneumatic Powered (Class I — General Controls, product code GET), submitted by Sodem Diffusion SA (North Attleboro, US). The FDA issued a Cleared decision on January 22, 1996, 70 days after receiving the submission on November 13, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.