LOW PRESSURE TAMPONADE BALLOON CATHETER— 510(k) K941012

Name: FDA 510(k) clearance K941012
Creator: U.S. Food and Drug Administration
Published: 1994-04-18

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K941012 for LOW PRESSURE TAMPONADE BALLOON CATHETER, Substantially Equivalent on 1994-04-18. Applicant: Applied Medical Resources. Device class: 2.

Clearance details

Applicant: Applied Medical Resources
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1994-03-03
Decision date: 1994-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

Download summary PDF View on FDA.gov ↗

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