SCALPEL, ONE-PIECE, DISPOSABLE— 510(k) K854857

Name: FDA 510(k) clearance K854857
Creator: U.S. Food and Drug Administration
Published: 1985-12-24

Substantially Equivalent

Medelec Intl. Corp.

FDA 510(k) clearance K854857 for SCALPEL, ONE-PIECE, DISPOSABLE, Substantially Equivalent on 1985-12-24. Applicant: Medelec Intl. Corp.. Device class: 1.

Clearance details

Applicant: Medelec Intl. Corp.
Product code: Code GDX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-12-05
Decision date: 1985-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

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