FDA 510(k) Application Details - K041360

Device Classification Name	Sterilant, Medical Devices   More FDA Info for this Device
510(K) Number	K041360
Device Name	Sterilant, Medical Devices
Applicant	HEALTHPOINT, LTD. 1107-C S. AIRPORT CIRCLE EULESS (DALLAS), TX 76040 US Other 510(k) Applications for this Company
Contact	NORM MINER, PHD 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	05/21/2004
Decision Date	05/05/2005
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