FDA 510(k) Application Details - K181488

Device Classification Name	Clip, Implantable   More FDA Info for this Device
510(K) Number	K181488
Device Name	Clip, Implantable
Applicant	Ethicon Endo-Surgery, LLC 475 Calle C Suite 202 Guynabo, PR 00969 US Other 510(k) Applications for this Company
Contact	Sigfrido Delgado Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	FZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2018
Decision Date	10/30/2018
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