FDA 510(k) Application Details - K134040

Device Classification Name	More FDA Info for this Device
510(K) Number	K134040
Device Name	BTL-9000; BTL-9000 RADIOFREQUENCY MODULE
Applicant	BTL INDUSTRIES LTD 16 APPLETON STREET WALTHAM, MA 02453 US Other 510(k) Applications for this Company
Contact	MICHAIL M PANKRATOV Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2013
Decision Date	09/10/2014
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