ALEXIS WOUND RETRACTOR— 510(k) K031889

Name: FDA 510(k) clearance K031889
Creator: U.S. Food and Drug Administration
Published: 2003-09-22

Substantially Equivalent

Applied Medical Resources Corp.

FDA 510(k) clearance K031889 for ALEXIS WOUND RETRACTOR, Substantially Equivalent on 2003-09-22. Applicant: Applied Medical Resources Corp.. Device class: 2.

Clearance details

Applicant: Applied Medical Resources Corp.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2003-06-18
Decision date: 2003-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, CA, US

Download summary PDF View on FDA.gov ↗

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