PERSONNA PLUS SAFETY SCALPEL SYSTEM— 510(k) K032242

Name: FDA 510(k) clearance K032242
Creator: U.S. Food and Drug Administration
Published: 2003-09-23

Substantially Equivalent

Omi Manufacturing Pty., Ltd.

FDA 510(k) clearance K032242 for PERSONNA PLUS SAFETY SCALPEL SYSTEM, Substantially Equivalent on 2003-09-23. Applicant: Omi Manufacturing Pty., Ltd.. Device class: 1.

Clearance details

Applicant: Omi Manufacturing Pty., Ltd.
Product code: Code GES
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2003-07-21
Decision date: 2003-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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