DISPOSABLE SHOE COVER— 510(k) K894383

Name: FDA 510(k) clearance K894383
Creator: U.S. Food and Drug Administration
Published: 1989-09-12

Substantially Equivalent

American Threshold Industries, Inc.

FDA 510(k) clearance K894383 for DISPOSABLE SHOE COVER, Substantially Equivalent on 1989-09-12. Applicant: American Threshold Industries, Inc.. Device class: 1.

Clearance details

Applicant: American Threshold Industries, Inc.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1989-07-17
Decision date: 1989-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Enka, 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.