UNIPOLAR OPTICAL BIOPSY FORCEPS— 510(k) K983811

Name: FDA 510(k) clearance K983811
Creator: U.S. Food and Drug Administration
Published: 1998-12-24

Substantially Equivalent

Olympus Winter & Ibe GmbH

FDA 510(k) clearance K983811 for UNIPOLAR OPTICAL BIOPSY FORCEPS, Substantially Equivalent on 1998-12-24. Applicant: Olympus Winter & Ibe GmbH. Device class: 2.

Clearance details

Applicant: Olympus Winter & Ibe GmbH
Product code: Code KGE
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 1998-10-28
Decision date: 1998-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, 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.