FDA 510(k) Application Details - K043138

Device Classification Name	Prosthesis, Laryngeal (Taub)   More FDA Info for this Device
510(K) Number	K043138
Device Name	Prosthesis, Laryngeal (Taub)
Applicant	ATOS MEDICAL AB KRAFTGATAN 8 HORBY SE-242 22 SE Other 510(k) Applications for this Company
Contact	EDDY ABERG 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	11/12/2004
Decision Date	11/22/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review