FDA 510(k) Application Details - K112734

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K112734
Device Name	Needle, Fistula
Applicant	APLAN WELL ENTERPRISE CO., LTD NO. 58, FU CHIUN STREET HSIN CHU CITY 30067 TW Other 510(k) Applications for this Company
Contact	JEN KE-MIN Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	FIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2011
Decision Date	04/24/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review