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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 K140742
Device Name RELIANCE ANTERIOR CERVICAL PLATE
Applicant
Reliance Medical Systems, LLC
P.O. Box 1693
Bountiful,  UT  84010
Applicant Contact Bret M Berry
Correspondent
Reliance Medical Systems, LLC
P.O. Box 1693
Bountiful,  UT  84010
Correspondent Contact Bret M Berry
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/25/2014
Decision Date 04/25/2014
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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