OLYMPUS CD-6C-1 COAGULATION ELECTRODE— 510(k) K971328

Name: FDA 510(k) clearance K971328
Creator: U.S. Food and Drug Administration
Published: 1997-07-01

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K971328 for OLYMPUS CD-6C-1 COAGULATION ELECTRODE, Substantially Equivalent on 1997-07-01. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code FFE
Device class: Class 2
Regulation: 21 CFR 876.4650
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-10
Decision date: 1997-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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