510(k) K132570

ELECTRIC HANDPIECE SYSTEM by Ttbio Corp. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2014
Date Received
August 15, 2013
Clearance Type
Abbreviated
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