FDA 510(k) Application Details - K182235

Device Classification Name	Container, Sharps   More FDA Info for this Device
510(K) Number	K182235
Device Name	Container, Sharps
Applicant	Bluestone Medical, Inc. (DBA OnSite Waste Technologies, Inc.) 9 North Main Street East Hampton, NY 11937 US Other 510(k) Applications for this Company
Contact	Jon Bricken 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	08/17/2018
Decision Date	05/20/2019
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