GUIBOR MICROELECTROLYSIS UNIT 18— 510(k) K851318

Name: FDA 510(k) clearance K851318
Creator: U.S. Food and Drug Administration
Published: 1985-08-20

Substantially Equivalent

Galvanic Medical Instruments, Inc.

FDA 510(k) clearance K851318 for GUIBOR MICROELECTROLYSIS UNIT 18, Substantially Equivalent on 1985-08-20. Applicant: Galvanic Medical Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Galvanic Medical Instruments, Inc.
Product code: Code KCW
Device class: Class 1
Regulation: 21 CFR 878.5350
Advisory panel: General, Plastic Surgery
Date received: 1985-04-02
Decision date: 1985-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

Download summary PDF View on FDA.gov ↗

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