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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 K023096
Device Name CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
Applicant
STD MFG., INC.
1063 TURNPIKE ST.
P.O. BOX 420
STOUGHTON,  MA  02072
Applicant Contact STEVE EK
Correspondent
STD MFG., INC.
1063 TURNPIKE ST.
P.O. BOX 420
STOUGHTON,  MA  02072
Correspondent Contact STEVE EK
Regulation Number888.3690
Classification Product Code
HSD  
Date Received09/18/2002
Decision Date 04/10/2003
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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