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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Femoral, Resurfacing
510(k) Number K021549
Device Name CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
Applicant
Std Mfg., Inc.
1063 Tpke. St.
P.O. Box 420
Stoughton,  MA  02072
Applicant Contact STEVE EK
Correspondent
Std Mfg., Inc.
1063 Tpke. St.
P.O. Box 420
Stoughton,  MA  02072
Correspondent Contact STEVE EK
Regulation Number888.3400
Classification Product Code
KXA  
Date Received05/13/2002
Decision Date 08/01/2002
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
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