FDA 510(k) Application Details - K161024

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K161024
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	Canadian Technical Tape, Ltd. 455 Cote-Vertu Blvd Montreal h4n 1E8 CA Other 510(k) Applications for this Company
Contact	Howard Cohen Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	JOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2016
Decision Date	06/28/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review