SMITH & NEPHEW DYONICS LEVELERT SYSTEM— 510(k) K903193

Name: FDA 510(k) clearance K903193
Creator: U.S. Food and Drug Administration
Published: 1990-08-30

Substantially Equivalent

Smith & Nephew Dyonics, Inc.

FDA 510(k) clearance K903193 for SMITH & NEPHEW DYONICS LEVELERT SYSTEM, Substantially Equivalent on 1990-08-30. Applicant: Smith & Nephew Dyonics, Inc.. Device class: 2.

Clearance details

Applicant: Smith & Nephew Dyonics, Inc.
Product code: Code FLN
Device class: Class 2
Regulation: 21 CFR 880.2420
Advisory panel: General Hospital
Date received: 1990-07-19
Decision date: 1990-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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