FDA 510(k) Application Details - K193652

Device Classification Name	Endoscopic Tissue Approximation Device   More FDA Info for this Device
510(K) Number	K193652
Device Name	Endoscopic Tissue Approximation Device
Applicant	Medeon Biodesign, Inc. 7F, 116, HouGang St., Taipei 11170 TW Other 510(k) Applications for this Company
Contact	Tsung-Yu Hsieh Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2019
Decision Date	03/26/2020
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