FDA 510(k) Application Details - K974527

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K974527
Device Name	Needle, Acupuncture, Single Use
Applicant	AMERICAN INSTITUTE OF KORYO HAND THERAPY 1800 CENTURY PARK EAST. SUITE 600 LOS ANGELES, CA 90067 US Other 510(k) Applications for this Company
Contact	JIN HAE LEW 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	12/02/1997
Decision Date	01/13/1998
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