UNIVERSAL SUTURE PASSER— 510(k) K812566

Name: FDA 510(k) clearance K812566
Creator: U.S. Food and Drug Administration
Published: 1981-11-10

Substantially Equivalent

Ortho Pared Instruments, Inc.

FDA 510(k) clearance K812566 for UNIVERSAL SUTURE PASSER, Substantially Equivalent on 1981-11-10. Applicant: Ortho Pared Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Ortho Pared Instruments, Inc.
Product code: Code GDL
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1981-09-09
Decision date: 1981-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.