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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K892638
Device Name TRACER DYNAMIC AXIAL FIXATION
Applicant
Tracer Medical
333 S. 11th St.
Santa Paula,  CA  93060
Applicant Contact VINCE DECOST
Correspondent
Tracer Medical
333 S. 11th St.
Santa Paula,  CA  93060
Correspondent Contact VINCE DECOST
Regulation Number888.3040
Classification Product Code
JEC  
Date Received04/12/1989
Decision Date 08/11/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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