FDA 510(k) Application Details - K170003

Device Classification Name	More FDA Info for this Device
510(K) Number	K170003
Device Name	Zip 4 Skin Closure Device
Applicant	ZipLine Medical, Inc. 747 Camden Ave, Suite A Campbell, CA 95008 US Other 510(k) Applications for this Company
Contact	Trish Howell Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2017
Decision Date	08/18/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review