FDA 510(k) Application Details - K151117

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K151117
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Medeon Biodesign, Inc 7F, 116 Hougang St Taipei 11170 TW Other 510(k) Applications for this Company
Contact	Greta Chang Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2015
Decision Date	08/20/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review