FDA 510(k) Application Details - K141580

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K141580
Device Name	Indicator, Biological Sterilization Process
Applicant	TSO3 INC. 512F NE 81ST STREET, SUITE 101 VANCOUVER, WA 98665 US Other 510(k) Applications for this Company
Contact	THOMAS RICHARDS Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	FRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2014
Decision Date	12/17/2014
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