FDA 510(k) Application Details - K140382

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K140382
Device Name	Prosthesis, Tracheal, Expandable
Applicant	MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	DAN LINDSAY 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	02/14/2014
Decision Date	11/25/2014
Decision	SESE - SUBST EQUIV
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