FDA 510(k) Application Details - K113015

Device Classification Name	Sterilant, Medical Devices   More FDA Info for this Device
510(K) Number	K113015
Device Name	Sterilant, Medical Devices
Applicant	MICROCHEM LABORATORIES, INC. 1107-C SOUTH AIRPORT CIRCLE EULESS, TX 76040 US Other 510(k) Applications for this Company
Contact	NORMAN MINER Other 510(k) Applications for this Contact
Regulation Number	880.6885   More FDA Info for this Regulation Number
Classification Product Code	MED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2011
Decision Date	01/30/2012
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