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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 EAST BELL DR.
BOX 587
warsaw,  IN  46581 -0587
Applicant Contact patricia s beres
Correspondent
BIOMET, INC.
56 EAST 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
Recalls CDRH Recalls
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