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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, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K131112
Device Name LIMACORPORATE SMR CTA HUMERAL HEADS
Applicant
Lima Corporate S.P.A.
P.O. Box 696
Winona Lake,  IN  46590 -696
Applicant Contact CHERYL HASTINGS
Correspondent
Lima Corporate S.P.A.
P.O. Box 696
Winona Lake,  IN  46590 -696
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received04/22/2013
Decision Date 06/07/2013
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
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