OMED DISPOSABLE SCALPEL— 510(k) K880028

Name: FDA 510(k) clearance K880028
Creator: U.S. Food and Drug Administration
Published: 1988-01-29

Substantially Equivalent

Oxboro Medical Intl., Inc.

FDA 510(k) clearance K880028 for OMED DISPOSABLE SCALPEL, Substantially Equivalent on 1988-01-29. Applicant: Oxboro Medical Intl., Inc.. Device class: 1.

Clearance details

Applicant: Oxboro Medical Intl., Inc.
Product code: Code GDX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1988-01-05
Decision date: 1988-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

Download summary PDF View on FDA.gov ↗

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