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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 K013042
Device Name DISCOVERY ELBOW
Applicant
Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact SARA B SHULTZ
Correspondent
Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact SARA B SHULTZ
Regulation Number888.3150
Classification Product Code
JDC  
Date Received09/10/2001
Decision Date 10/10/2001
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
Recalls CDRH Recalls
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