FDA 510(k) Application Details - K974616

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K974616
Device Name	Needle, Acupuncture, Single Use
Applicant	LORAC, INC. 134 NORTH WASHINGTON ST. NAPERVILLE,, IL 60540 US Other 510(k) Applications for this Company
Contact	SANDRA SOBCZAK 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	12/11/1997
Decision Date	02/05/1998
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