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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Traction, Powered
510(k) Number K151640
Device Name ELTRAC 471
Applicant
ENRAF-NONIUS B.V.
VARSEWEG 127
ROTTERDAM,  NL 3047 AT
Applicant Contact ANNE-MARIE VAN MAURIK
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number890.5900
Classification Product Code
ITH  
Date Received06/18/2015
Decision Date 10/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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