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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 K073349
Device Name RELIANCE BUTTRESS WASHER SYSTEM
Applicant
Reliance Medical Systems, LLC
2647 Cassowary Cir
Sandy,  UT  84092 -7116
Applicant Contact Bret M Berry
Correspondent
Reliance Medical Systems, LLC
2647 Cassowary Cir
Sandy,  UT  84092 -7116
Correspondent Contact Bret M Berry
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/29/2007
Decision Date 02/13/2008
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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