FDA 510(k) Application Details - K023054

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K023054
Device Name	Needle, Acupuncture, Single Use
Applicant	MANDALA HEALTH CARE, LLC 4320 SPRING VALLEY RD., DALLAS, TX 75244-4352 US Other 510(k) Applications for this Company
Contact	DASHIMA DOVCHIN Other 510(k) Applications for this Contact
Regulation Number	880.5580   More FDA Info for this Regulation Number
Classification Product Code	MQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2002
Decision Date	11/13/2002
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