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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 K822885
Device Name HALO TRACTION CERVICAL IMMOBILIZATION
Applicant
Orthopedic Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Orthopedic Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.5960
Classification Product Code
HAX  
Date Received09/28/1982
Decision Date 11/22/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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