COAXIAL BALLOON URETHRAL DILATOR— 510(k) K831384

Name: FDA 510(k) clearance K831384
Creator: U.S. Food and Drug Administration
Published: 1983-07-26

Substantially Equivalent

Thomas J. Fogarty, M.D.

FDA 510(k) clearance K831384 for COAXIAL BALLOON URETHRAL DILATOR, Substantially Equivalent on 1983-07-26. Applicant: Thomas J. Fogarty, M.D.. Device class: 2.

Clearance details

Applicant: Thomas J. Fogarty, M.D.
Product code: Code FAH
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1983-04-28
Decision date: 1983-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Thomas J. Fogarty, M.D.

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K841310 — GASTROINTESTINAL DILATOR1984-07-31
K834451 — COAXIAL BALLOON GASTROESOPHAGEAL DILA1984-02-04

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