FDA 510(k) Application Details - K082284

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K082284
Device Name	Prosthesis, Tracheal, Expandable
Applicant	ALVEOLUS, INC 9013 PERIMETER WOODS DR. SUITE A CHARLOTTE, NC 28216 US Other 510(k) Applications for this Company
Contact	TONY ALEXANDER Other 510(k) Applications for this Contact
Regulation Number	878.3720   More FDA Info for this Regulation Number
Classification Product Code	JCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2008
Decision Date	11/20/2008
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review