FDA 510(k) Application Details - K042132

Device Classification Name	Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women   More FDA Info for this Device
510(K) Number	K042132
Device Name	Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
Applicant	NOVASYS MEDICAL, INC. 39684 EUREKA DR. NEWARK, CA 94560 US Other 510(k) Applications for this Company
Contact	DEBRA REISENTHEL Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	NVJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2004
Decision Date	12/21/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review