FDA 510(k) Application Details - K141473

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K141473
Device Name	Needle, Acupuncture, Single Use
Applicant	SMC INTL., INC. JISAN IT VENTURE CENTER 601 15, BEOTKKOT-RO 12-GIL, GEUMCHEON-GU SEOUL 153-289 KR Other 510(k) Applications for this Company
Contact	JONG-MAN LEE 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	06/03/2014
Decision Date	08/01/2014
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