FDA 510(k) Application Details - K970260

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K970260
Device Name	Needle, Acupuncture, Single Use
Applicant	SEIRIN-AMERICA, INC. 230 LIBBEY PKWY. WEYMOUTH, MA 02189 US Other 510(k) Applications for this Company
Contact	THOMAS A RIIHIMAKI 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	01/23/1997
Decision Date	02/10/1997
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