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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K884407
Device Name TRACER SKELETAL TRACTION PINS
Applicant
De Medica Mfg., Inc.
333 S. 11th St.
Santa Paula,  CA  93060
Correspondent
De Medica Mfg., Inc.
333 S. 11th St.
Santa Paula,  CA  93060
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/19/1988
Decision Date 11/28/1988
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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