FDA 510(k) Application Details - K211577

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K211577
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Unimax Medical Systems Inc. 8F-2, No. 127, Lane 235, Pao Chiao Road New Taipei 23145a TW Other 510(k) Applications for this Company
Contact	Monoj Mon Kalita 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	05/21/2021
Decision Date	11/05/2021
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