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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tong, Skull For Traction
510(k) Number K980689
Device Name FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
Applicant
Friddle'S Orthopedic Appliances, Inc.
12306 Belton Honea Path Hwy.
Honea Path,  SC  29654
Applicant Contact FRANK E FRIDDLE, JR.
Correspondent
Friddle'S Orthopedic Appliances, Inc.
12306 Belton Honea Path Hwy.
Honea Path,  SC  29654
Correspondent Contact FRANK E FRIDDLE, JR.
Regulation Number882.5960
Classification Product Code
HAX  
Date Received02/23/1998
Decision Date 02/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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