ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR— 510(k) K010711

Name: FDA 510(k) clearance K010711
Creator: U.S. Food and Drug Administration
Published: 2001-05-22

Substantially Equivalent

Advanced Surgical Concepts (Asc)

FDA 510(k) clearance K010711 for ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR, Substantially Equivalent on 2001-05-22. Applicant: Advanced Surgical Concepts (Asc). Device class: 2.

Clearance details

Applicant: Advanced Surgical Concepts (Asc)
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2001-03-09
Decision date: 2001-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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