FDA 510(k) Application Details - K193110

Device Classification Name	More FDA Info for this Device
510(K) Number	K193110
Device Name	3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Applicant	3M Health Care 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul, MN 55144-1000 US Other 510(k) Applications for this Company
Contact	Andrew Wingen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2019
Decision Date	03/13/2020
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