FDA 510(k) Application Details - K061517

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K061517
Device Name	Needle, Acupuncture, Single Use
Applicant	PRIME HERBS CORPORATION 754 SAN ALESO AVE. SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	GENEVIEVE HSIA 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	06/01/2006
Decision Date	11/22/2006
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