FDA 510(k) Application Details - K190937

Device Classification Name	More FDA Info for this Device
510(K) Number	K190937
Device Name	Echelon Endopath Staple Line Reinforcement
Applicant	Ethicon Endo-Surgery LLC 475 Calle C Guaynabo, PR 00696 US Other 510(k) Applications for this Company
Contact	Emily Nesbitt Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2019
Decision Date	10/14/2019
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