SURE COUNT LIGHT HANDLE COVER— 510(k) K890539

Name: FDA 510(k) clearance K890539
Creator: U.S. Food and Drug Administration
Published: 1989-02-27

Substantially Equivalent

Kleen Test Products

FDA 510(k) clearance K890539 for SURE COUNT LIGHT HANDLE COVER, Substantially Equivalent on 1989-02-27. Applicant: Kleen Test Products. Device class: 2.

Clearance details

Applicant: Kleen Test Products
Product code: Code FTA
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1989-02-03
Decision date: 1989-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhorn, WI, 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.