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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 K072578
Device Name SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
Applicant
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact SHERI MUSGNUNG
Correspondent
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact SHERI MUSGNUNG
Regulation Number888.3690
Classification Product Code
HSD  
Subsequent Product Codes
KWT   MBF  
Date Received09/13/2007
Decision Date 11/28/2007
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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