FDA 510(k) Application Details - K180757

Device Classification Name	Clip, Aneurysm   More FDA Info for this Device
510(K) Number	K180757
Device Name	Clip, Aneurysm
Applicant	Peter Lazic GmbH Immelmannweg 2 Tuttlingen 78532 DE Other 510(k) Applications for this Company
Contact	Sven Lazic Other 510(k) Applications for this Contact
Regulation Number	882.5200   More FDA Info for this Regulation Number
Classification Product Code	HCH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2018
Decision Date	04/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review