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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K961571
Device Name COCR BI-ANGULAR HUMERAL COMPONENT
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact JOHN WAGGONER
Correspondent
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact JOHN WAGGONER
Regulation Number888.3650
Classification Product Code
KWT  
Date Received04/23/1996
Decision Date 08/05/1996
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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