FDA 510(k) Application Details - K132896

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K132896
Device Name	Needle, Acupuncture, Single Use
Applicant	ASIA-MED GMBH AND CO KG 33 Golden Eagle Lane Littleton, CO 80127 US Other 510(k) Applications for this Company
Contact	Kevin Walls 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	09/16/2013
Decision Date	12/02/2013
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