510(k) K972924

SURGIC II IMPLANT CONTROL UNIT by Nsk Nakanishi, Inc. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1997
Date Received
August 8, 1997
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