SPACE-OR RETRACTOR— 510(k) K993544

Name: FDA 510(k) clearance K993544
Creator: U.S. Food and Drug Administration
Published: 1999-12-22

Substantially Equivalent

Advanced Surgical Concepts (Asc)

FDA 510(k) clearance K993544 for SPACE-OR RETRACTOR, Substantially Equivalent on 1999-12-22. Applicant: Advanced Surgical Concepts (Asc). Device class: 1.

Clearance details

Applicant: Advanced Surgical Concepts (Asc)
Product code: Code FFO
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1999-10-19
Decision date: 1999-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.