FDA 510(k) Application Details - K043277

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K043277
Device Name	Needle, Acupuncture, Single Use
Applicant	HELIO MEDICAL SUPPLIES, INC. 606 CHARCOT AVE. SAN JOSE, CA 95131 US Other 510(k) Applications for this Company
Contact	ERIC CHENG 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	11/26/2004
Decision Date	02/08/2005
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