FDA 510(k) Application Details - K093258

Device Classification Name	Prosthesis, Laryngeal (Taub)   More FDA Info for this Device
510(K) Number	K093258
Device Name	Prosthesis, Laryngeal (Taub)
Applicant	HELIX MEDICAL, LLC 1110 MARK AVE. CARPINTERIA, CA 93013 US Other 510(k) Applications for this Company
Contact	CYNTHIA ANDERSON 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	10/19/2009
Decision Date	03/03/2010
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