WILTEK NASAL BILIARY DRAINAGE SET— 510(k) K894870

Name: FDA 510(k) clearance K894870
Creator: U.S. Food and Drug Administration
Published: 1989-12-21

Substantially Equivalent

Wiltek Medical, Inc.

FDA 510(k) clearance K894870 for WILTEK NASAL BILIARY DRAINAGE SET, Substantially Equivalent on 1989-12-21. Applicant: Wiltek Medical, Inc.. Device class: 2.

Clearance details

Applicant: Wiltek Medical, Inc.
Product code: Code BSS
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1989-07-31
Decision date: 1989-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

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