VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET— 510(k) K870556

Name: FDA 510(k) clearance K870556
Creator: U.S. Food and Drug Administration
Published: 1987-03-10

Substantially Equivalent

Van-Tec, Inc.

FDA 510(k) clearance K870556 for VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET, Substantially Equivalent on 1987-03-10. Applicant: Van-Tec, Inc.. Device class: 2.

Clearance details

Applicant: Van-Tec, Inc.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1987-02-10
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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