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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K080642
Device Name COMPREHENSIVE REVERSE SHOULDER
Applicant
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581 -0587
Applicant Contact PATRICIA S BERES
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact PATRICIA S BERES
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received03/06/2008
Decision Date 07/09/2008
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
Recalls CDRH Recalls
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