WILTEK IRRIGAITON/ASPIRATION TUBE SET— 510(k) K922989

Name: FDA 510(k) clearance K922989
Creator: U.S. Food and Drug Administration
Published: 1994-02-15

Substantially Equivalent

Wiltek Medical, Inc.

FDA 510(k) clearance K922989 for WILTEK IRRIGAITON/ASPIRATION TUBE SET, Substantially Equivalent on 1994-02-15. Applicant: Wiltek Medical, Inc.. Device class: 2.

Clearance details

Applicant: Wiltek Medical, Inc.
Product code: Code BYY
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1992-06-22
Decision date: 1994-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, 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.