FDA 510(k) Application Details - K043135

Device Classification Name	Indicator, Biological, Liquid Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K043135
Device Name	Indicator, Biological, Liquid Chemical Sterilization Process
Applicant	SPS MEDICAL SUPPLY CORP. 6789 WEST HENRIETTA RD. RUSH, NY 14543 US Other 510(k) Applications for this Company
Contact	GARY J SCOLA Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	MRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2004
Decision Date	01/13/2005
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