SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY— 510(k) K955174

Name: FDA 510(k) clearance K955174
Creator: U.S. Food and Drug Administration
Published: 1996-01-22

Substantially Equivalent

Sodem Diffusion SA

FDA 510(k) clearance K955174 for SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY, Substantially Equivalent on 1996-01-22. Applicant: Sodem Diffusion SA. Device class: 1.

Clearance details

Applicant: Sodem Diffusion SA
Product code: Code GET
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1995-11-13
Decision date: 1996-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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K954717 — SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY1997-01-22
K954080 — SODEM HIGH SPEED SYSTEM1995-10-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.