FDA 510(k) Application Details - K092593

Device Classification Name	Prosthesis, Laryngeal (Taub)   More FDA Info for this Device
510(K) Number	K092593
Device Name	Prosthesis, Laryngeal (Taub)
Applicant	ATOS MEDICAL AB KRAFTGATAN 8 HORBY SE-24222 SE Other 510(k) Applications for this Company
Contact	FERENC DAHNER Other 510(k) Applications for this Contact
Regulation Number	874.3730   More FDA Info for this Regulation Number
Classification Product Code	EWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2009
Decision Date	10/14/2010
Decision	SESK - SUBST EQUIV - KIT
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