2.5 FRENCH LITHOTRIPTOR ELECTRODE— 510(k) K894704

Name: FDA 510(k) clearance K894704
Creator: U.S. Food and Drug Administration
Published: 1989-10-18

Substantially Equivalent

Northgate Research, Inc.

FDA 510(k) clearance K894704 for 2.5 FRENCH LITHOTRIPTOR ELECTRODE, Substantially Equivalent on 1989-10-18. Applicant: Northgate Research, Inc.. Device class: 2.

Clearance details

Applicant: Northgate Research, Inc.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1989-07-25
Decision date: 1989-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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