FDA 510(k) Application Details - K043506

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K043506
Device Name	Needle, Acupuncture, Single Use
Applicant	MARKNEW PRODUCTS 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	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	12/20/2004
Decision Date	02/11/2005
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