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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, hemi-, femoral, metal
510(k) Number K071471
Device Name CORIN ADAPTOR SLEEVE
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact KAREN ARIEMMA
Correspondent
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact KAREN ARIEMMA
Regulation Number888.3360
Classification Product Code
KWL  
Date Received05/29/2007
Decision Date 09/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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