FDA 510(k) Application Details - K022156

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K022156
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG JERAM, SELANGOR DARUL EHSAN 45800 MY Other 510(k) Applications for this Company
Contact	KOI-YONG LIM Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2002
Decision Date	09/11/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review