FREEDOM TRAVELLER— 510(k) K964825

Name: FDA 510(k) clearance K964825
Creator: U.S. Food and Drug Administration
Published: 1997-05-19

Substantially Equivalent

Impact Case Technologies, Inc.

FDA 510(k) clearance K964825 for FREEDOM TRAVELLER, Substantially Equivalent on 1997-05-19. Applicant: Impact Case Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Impact Case Technologies, Inc.
Product code: Code MLW
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1996-12-02
Decision date: 1997-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Markham, Ontario, CA

Download summary PDF View on FDA.gov ↗

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