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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 K081016
Device Name SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
Applicant
SMITH & NEPHEW, INC.
1450 E BROOKS ROAD
MEMPHIS,  TN  38116
Applicant Contact JASON SELLS
Correspondent
SMITH & NEPHEW, INC.
1450 E BROOKS ROAD
MEMPHIS,  TN  38116
Correspondent Contact JASON SELLS
Regulation Number888.3660
Classification Product Code
PHX  
Date Received04/09/2008
Decision Date 09/05/2008
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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