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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 K981008
Device Name SIMAL CERVICAL STABILIZATION SYSTEM
Applicant
Top Surgical Products GmbH
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
Top Surgical Products GmbH
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/18/1998
Decision Date 05/27/1998
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
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