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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K973145
Device Name TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM
Applicant
Sofamor Danek USA,Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE
Correspondent
Sofamor Danek USA,Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE
Regulation Number872.4760
Classification Product Code
JEY  
Date Received08/22/1997
Decision Date 11/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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