APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE— 510(k) K951721

Name: FDA 510(k) clearance K951721
Creator: U.S. Food and Drug Administration
Published: 1995-07-11

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K951721 for APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE, Substantially Equivalent on 1995-07-11. Applicant: Applied Medical Resources. Device class: 2.

Clearance details

Applicant: Applied Medical Resources
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1995-04-14
Decision date: 1995-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

Download summary PDF View on FDA.gov ↗

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