(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE— 510(k) K870355

Name: FDA 510(k) clearance K870355
Creator: U.S. Food and Drug Administration
Published: 1987-04-01

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K870355 for (URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE, Substantially Equivalent on 1987-04-01. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code OCZ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1987-01-29
Decision date: 1987-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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