WOUND PROTECTOR/RETRACTOR— 510(k) K020435

Name: FDA 510(k) clearance K020435
Creator: U.S. Food and Drug Administration
Published: 2002-04-15

Substantially Equivalent

Applied Medical Resources Corp.

FDA 510(k) clearance K020435 for WOUND PROTECTOR/RETRACTOR, Substantially Equivalent on 2002-04-15. 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: 2002-02-08
Decision date: 2002-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, CA, US

Download summary PDF View on FDA.gov ↗

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