FDA 510(k) Application Details - K991507

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K991507
Device Name	Needle, Acupuncture, Single Use
Applicant	HELIO MEDICAL SUPPLIES, INC. 2080A WALSH AVE. SANTA CLARA, CA 95050 US Other 510(k) Applications for this Company
Contact	YI-FEN CHANG 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	04/29/1999
Decision Date	08/27/1999
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