LINDNER/GOLOMB SP INTRODUCING SOUND— 510(k) K953024

Name: FDA 510(k) clearance K953024
Creator: U.S. Food and Drug Administration
Published: 1995-08-18

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K953024 for LINDNER/GOLOMB SP INTRODUCING SOUND, Substantially Equivalent on 1995-08-18. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1995-06-29
Decision date: 1995-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, 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.