FDA 510(k) Application Details - K974132

Device Classification Name	Prosthesis, Laryngeal (Taub)   More FDA Info for this Device
510(K) Number	K974132
Device Name	Prosthesis, Laryngeal (Taub)
Applicant	E. BENSON HOOD LAB, INC. 575 WASHINGTON ST. PEMBROKE, MA 02359 US Other 510(k) Applications for this Company
Contact	ANTHONY M SACCHETTI 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	11/03/1997
Decision Date	02/25/1998
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