FDA 510(k) Application Details - K982578

Device Classification Name	More FDA Info for this Device
510(K) Number	K982578
Device Name	QUANTI-TEST SYSTEM
Applicant	PANATREX, INC. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/1998
Decision Date	09/02/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review