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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nail, Fixation, Bone
510(k) Number K884406
Device Name TRACER HIP PINNING SYSTEM
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 Number888.3030
Classification Product Code
JDS  
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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