FDA 510(k) Application Details - K001257

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K001257
Device Name	Prosthesis, Tracheal, Expandable
Applicant	INTRATHERAPEUTICS, INC. 651 CAMPUS DR. ST. PAUL, MN 55112 US Other 510(k) Applications for this Company
Contact	MARIA E BRITTLE 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	04/19/2000
Decision Date	05/18/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review