SODEM HIGH SPEED SYSTEM— 510(k) K954080

Substantially Equivalent

Sodem Diffusion SA

FDA 510(k) clearance K954080 for SODEM HIGH SPEED SYSTEM, Substantially Equivalent on 1995-10-16. Applicant: Sodem Diffusion SA. Device class: 1.

Clearance details

Applicant: Sodem Diffusion SA
Product code: Code HSZ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1995-08-31
Decision date: 1995-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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