FDA 510(k) Application Details - K172719

Device Classification Name	Container, Sharps   More FDA Info for this Device
510(K) Number	K172719
Device Name	Container, Sharps
Applicant	HealthBeacon Ltd Unit 20, Naas Road Business Park, Muirfield Drive Dublin Dublin 12 IE Other 510(k) Applications for this Company
Contact	Joyce Power Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	MMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2017
Decision Date	05/11/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review