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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K061808
Device Name DARCO LOCKING BONE PLATE SYSTEM
Applicant
Darco International, Inc.
810 Memorial Blvd.
Huntington,  WV  25701
Applicant Contact MARK S COOPER
Correspondent
Darco International, Inc.
810 Memorial Blvd.
Huntington,  WV  25701
Correspondent Contact MARK S COOPER
Regulation Number888.3030
Classification Product Code
HRS  
Date Received06/27/2006
Decision Date 08/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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