URETHRAL SUTURE GUIDE— 510(k) K950267

Name: FDA 510(k) clearance K950267
Creator: U.S. Food and Drug Administration
Published: 1995-01-31

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K950267 for URETHRAL SUTURE GUIDE, Substantially Equivalent on 1995-01-31. Applicant: Applied Medical Resources. Device class: 1.

Clearance details

Applicant: Applied Medical Resources
Product code: Code KOA
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1995-01-23
Decision date: 1995-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

Download summary PDF View on FDA.gov ↗

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