FDA 510(k) Application Details - K040525

Device Classification Name	Ultrasound, Skin Permeation   More FDA Info for this Device
510(K) Number	K040525
Device Name	Ultrasound, Skin Permeation
Applicant	SONTRA MEDICAL INC. 10 FORGE PARKWAY FRANKLIN, MA 02038 US Other 510(k) Applications for this Company
Contact	ALBERT FARINHA Other 510(k) Applications for this Contact
Regulation Number	878.4410   More FDA Info for this Regulation Number
Classification Product Code	NRJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2004
Decision Date	08/17/2004
Decision	SESK - SUBST EQUIV - KIT
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