VAN-TEC URETHRAL DILATATION SYSTEM— 510(k) K870695

Name: FDA 510(k) clearance K870695
Creator: U.S. Food and Drug Administration
Published: 1987-03-10

Substantially Equivalent

Van-Tec, Inc.

FDA 510(k) clearance K870695 for VAN-TEC URETHRAL DILATATION SYSTEM, Substantially Equivalent on 1987-03-10. Applicant: Van-Tec, Inc.. Device class: 2.

Clearance details

Applicant: Van-Tec, Inc.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1987-02-19
Decision date: 1987-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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