FDA 510(k) Application Details - K091135

Device Classification Name	Prosthesis, Larynx (Stents And Keels)   More FDA Info for this Device
510(K) Number	K091135
Device Name	Prosthesis, Larynx (Stents And Keels)
Applicant	BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. WESTBOROUGH, MA 01581 US Other 510(k) Applications for this Company
Contact	MICHAEL A WARREN 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	04/20/2009
Decision Date	09/14/2009
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