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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 K984202
Device Name HOWMEDICA HUMERAL INTERCALARY SYSTEM
Applicant
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact FRANK MAAS
Correspondent
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact FRANK MAAS
Regulation Number888.3690
Classification Product Code
HSD  
Date Received11/24/1998
Decision Date 02/05/1999
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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