FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM— 510(k) K980689

Name: FDA 510(k) clearance K980689
Creator: U.S. Food and Drug Administration
Published: 1999-02-18

Substantially Equivalent

Friddle'S Orthopedic Appliances, Inc.

FDA 510(k) clearance K980689 for FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM, Substantially Equivalent on 1999-02-18. Applicant: Friddle'S Orthopedic Appliances, Inc.. Device class: 2.

Clearance details

Applicant: Friddle'S Orthopedic Appliances, Inc.
Product code: Code HAX
Device class: Class 2
Regulation: 21 CFR 882.5960
Advisory panel: Neurology
Date received: 1998-02-23
Decision date: 1999-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Honea Path, SC, US

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