FDA 510(k) Application Details - K971244

Device Classification Name	Prosthesis, Laryngeal (Taub)   More FDA Info for this Device
510(K) Number	K971244
Device Name	Prosthesis, Laryngeal (Taub)
Applicant	ATOS MEDICAL AB P.O. BOX 183 HORBY, SWEDEN SE-24222 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	04/03/1997
Decision Date	06/06/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review