510(k) K173905

Surgic Pro, Surgic Pro+ by Nakanishi, Inc. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2018
Date Received
December 22, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type