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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Mill
510(k) Number K883183
Device Name TRACER BONE MILL
Applicant
De Medica Mfg., Inc.
333 S. 11th St.
Santa Paula,  CA  93060
Applicant Contact VINCE DECOSTE
Correspondent
De Medica Mfg., Inc.
333 S. 11th St.
Santa Paula,  CA  93060
Correspondent Contact VINCE DECOSTE
Regulation Number888.4540
Classification Product Code
LYS  
Date Received07/28/1988
Decision Date 10/12/1988
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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