FDA 510(k) Application Details - K151640

Device Classification Name	Equipment, Traction, Powered   More FDA Info for this Device
510(K) Number	K151640
Device Name	Equipment, Traction, Powered
Applicant	ENRAF-NONIUS B.V. VARSEWEG 127 ROTTERDAM 3047 AT NL Other 510(k) Applications for this Company
Contact	ANNE-MARIE VAN MAURIK Other 510(k) Applications for this Contact
Regulation Number	890.5900   More FDA Info for this Regulation Number
Classification Product Code	ITH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/2015
Decision Date	10/16/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review