FDA 510(k) Application Details - K080838

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K080838
Device Name	Prosthesis, Esophageal
Applicant	ALVEOLUS, INC. 9013 PERIMETER WOODS DRIVE SUITE A CHARLOTTE, NC 28216 US Other 510(k) Applications for this Company
Contact	TONY D ALEXANDER Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	ESW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2008
Decision Date	04/24/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review