FDA 510(k) Application Details - K190005

Device Classification Name	Sterilizer, Chemical   More FDA Info for this Device
510(K) Number	K190005
Device Name	Sterilizer, Chemical
Applicant	Sterilucent, Inc. 1400 Marshall St. NE Minneapolis, MN 55413 US Other 510(k) Applications for this Company
Contact	Peter Kalkbrenner Other 510(k) Applications for this Contact
Regulation Number	880.6860   More FDA Info for this Regulation Number
Classification Product Code	MLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2019
Decision Date	09/13/2019
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