VACURECT VACUUM CONSTRICTION DEVICE— 510(k) K032776

Name: FDA 510(k) clearance K032776
Creator: U.S. Food and Drug Administration
Published: 2003-10-03

Substantially Equivalent

Vacurect Manufacturing (Pty) , Ltd.

FDA 510(k) clearance K032776 for VACURECT VACUUM CONSTRICTION DEVICE, Substantially Equivalent on 2003-10-03. Applicant: Vacurect Manufacturing (Pty) , Ltd.. Device class: 2.

Clearance details

Applicant: Vacurect Manufacturing (Pty) , Ltd.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 2003-09-08
Decision date: 2003-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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