FDA 510(k) Application Details - K190027

Device Classification Name	More FDA Info for this Device
510(K) Number	K190027
Device Name	SteriStay
Applicant	Toul Meditech AB Tunbytorpsgatan 31 Vasteras 72137 SE Other 510(k) Applications for this Company
Contact	Tomas Hansson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/07/2019
Decision Date	05/10/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review