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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K911306
Device Name T-BOLT AND NUT
Applicant
Danek Medical, Inc.
3092 Director'S Row
Memphis,  TN  38131
Applicant Contact RICHARD W TREHARNE
Correspondent
Danek Medical, Inc.
3092 Director'S Row
Memphis,  TN  38131
Correspondent Contact RICHARD W TREHARNE
Regulation Number888.3030
Classification Product Code
HTN  
Date Received03/25/1991
Decision Date 09/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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