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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, Non-Constrained, Metal/Polymer Cemented
510(k) Number K010869
Device Name EPOCA CUSTOM OFFSET SHOULDER SYSTEM
Applicant
Argomedical AG
800 Vinal St., Suite B-210
Pittsburgh,  PA  15212
Applicant Contact DONALD A STEVENS
Correspondent
Argomedical AG
800 Vinal St., Suite B-210
Pittsburgh,  PA  15212
Correspondent Contact DONALD A STEVENS
Regulation Number888.3650
Classification Product Code
KWT  
Date Received03/23/2001
Decision Date 10/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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