FDA 510(k) Application Details - K160961

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K160961
Device Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant	MERIL LIFE SCIENCES PRIVATE LIMITED Bilakhia House, Survey No. 135/139 Muktanand Marg, Chala Vapi 396191 IN Other 510(k) Applications for this Company
Contact	Utpal Thakor Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2016
Decision Date	07/30/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review