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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 K121183
Device Name COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
Applicant
BIOMET CORPORATION
56 EAST BELL DRIVE
WARSAW,  IN  46580
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
BIOMET CORPORATION
56 EAST BELL DRIVE
WARSAW,  IN  46580
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   PAO  
Date Received04/18/2012
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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