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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(k) Number K111097
Device Name HUMELOCK CEMENTED SHOULDER PROSTHESIS
Applicant
Fx Solutions
1663 Rue De Majornas
Viriat,  FR 01440
Applicant Contact CHERYL HASTINGS
Correspondent
Fx Solutions
1663 Rue De Majornas
Viriat,  FR 01440
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3690
Classification Product Code
HSD  
Date Received04/20/2011
Decision Date 11/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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