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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 K111735
Device Name REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER
Applicant
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact TEFFANY HUTTO
Correspondent
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact TEFFANY HUTTO
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received06/21/2011
Decision Date 10/03/2011
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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