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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Carpal Trapezium
510(k) Number K040070
Device Name ARTELON SPACER CMC-1
Applicant
Artimplant AB
719 A St. NE
Washington,  DC  20002
Applicant Contact MARIE MARLOW
Correspondent
Artimplant AB
719 A St. NE
Washington,  DC  20002
Correspondent Contact MARIE MARLOW
Regulation Number888.3770
Classification Product Code
KYI  
Date Received01/14/2004
Decision Date 09/21/2004
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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