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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 K791548
Device Name REXTON HS(HEARING SYSTEM)
Applicant
Argosy Intl. (Usa), Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Argosy Intl. (Usa), Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3690
Classification Product Code
HSD  
Date Received08/13/1979
Decision Date 09/28/1979
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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