FDA 510(k) Application Details - K000154

Device Classification Name	Prosthesis, Larynx (Stents And Keels)   More FDA Info for this Device
510(K) Number	K000154
Device Name	Prosthesis, Larynx (Stents And Keels)
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	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2000
Decision Date	03/29/2000
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