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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Constrained, Cemented
510(k) Number K000003
Device Name TORNIER TOTAL ELBOW PROSTHESIS
Applicant
TORNIER
200 GREGORY LN.
SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
TORNIER
200 GREGORY LN.
SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3150
Classification Product Code
JDC  
Subsequent Product Code
JDB  
Date Received01/03/2000
Decision Date 10/02/2000
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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