BLADE, SCALPEL— 510(k) K854561

Substantially Equivalent

Medelec Intl. Corp.

FDA 510(k) clearance K854561 for BLADE, SCALPEL, Substantially Equivalent on 1985-12-02. Applicant: Medelec Intl. Corp.. Device class: 1.

Clearance details

Applicant: Medelec Intl. Corp.
Product code: Code GES
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-11-14
Decision date: 1985-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, 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.