FDA 510(k) Application Details - K003559

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K003559
Device Name	Masker, Tinnitus
Applicant	SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 PISCATAWAY, NJ 08855 US Other 510(k) Applications for this Company
Contact	DAVID S SLAVIN Other 510(k) Applications for this Contact
Regulation Number	874.3400   More FDA Info for this Regulation Number
Classification Product Code	KLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2000
Decision Date	04/26/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review