FDA 510(k) Application Details - K103277

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K103277
Device Name	Indicator, Biological Sterilization Process
Applicant	3M COMPANY-3M HEALTH CARE 3M CENTER, BLDG. 275-5W-06 ST. PAUL, MN 55133-1006 US Other 510(k) Applications for this Company
Contact	SUZANNE LEUNG 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	11/05/2010
Decision Date	04/19/2011
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