FDA 510(k) Application Details - K181200

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K181200
Device Name	Prosthesis, Tracheal, Expandable
Applicant	Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	David Thomas 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	05/07/2018
Decision Date	09/21/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review