FDA 510(k) Application Details - K171155

Device Classification Name	Handpiece, Rotary Bone Cutting   More FDA Info for this Device
510(K) Number	K171155
Device Name	Handpiece, Rotary Bone Cutting
Applicant	Nakanishi Inc. 700 Shimonhinata Kanuma-shi 322-8666 JP Other 510(k) Applications for this Company
Contact	Kimihiko Satoh Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	KMW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2017
Decision Date	11/21/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review