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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K982443
Device Name DOC VENTRAL CERVICAL STABILIZATION SYSTEM
Applicant
Depuy Motech Acromed
3303 Carnegie Ave.
Cleveland,  OH  44115
Applicant Contact WILLIAM CHRISTIANSON
Correspondent
Depuy Motech Acromed
3303 Carnegie Ave.
Cleveland,  OH  44115
Correspondent Contact WILLIAM CHRISTIANSON
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/14/1998
Decision Date 07/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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