FDA 510(k) Application Details - K161551

Device Classification Name	More FDA Info for this Device
510(K) Number	K161551
Device Name	TR-100
Applicant	BTL INDUSTRIES, INC. 47 LORING DRIVE FRAMINGHAM, MA 01702 US Other 510(k) Applications for this Company
Contact	Jan Zarsky Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2016
Decision Date	09/13/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review