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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 K141006
Device Name RSP HUMERAL SOCKET INSERT
Applicant
Djo Global
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact CHRISTINE CHESNUTT
Correspondent
Djo Global
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact CHRISTINE CHESNUTT
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received04/18/2014
Decision Date 06/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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