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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 K001419
Device Name SOLAR SHOULDER OFFSET HUMERAL HEAD
Applicant
Howmedica Osteonics Corp.
59 Rte. 17 S.
Allendale,  NJ  07401
Applicant Contact KAREN ARIEMMA
Correspondent
Howmedica Osteonics Corp.
59 Rte. 17 S.
Allendale,  NJ  07401
Correspondent Contact KAREN ARIEMMA
Regulation Number888.3690
Classification Product Code
HSD  
Subsequent Product Code
KWS  
Date Received05/05/2000
Decision Date 07/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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