TAMPONADE BALLOON CUFF— 510(k) K833859

Name: FDA 510(k) clearance K833859
Creator: U.S. Food and Drug Administration
Published: 1984-01-03

Substantially Equivalent

American Endoscopy, Inc.

FDA 510(k) clearance K833859 for TAMPONADE BALLOON CUFF, Substantially Equivalent on 1984-01-03. Applicant: American Endoscopy, Inc.. Device class: 2.

Clearance details

Applicant: American Endoscopy, Inc.
Product code: Code GCP
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1983-11-07
Decision date: 1984-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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