FDA 510(k) Application Details - K193161

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K193161
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Pristine Surgical Brady Sullivan Tower, 6th Floor, 1750 Elm Street Manchester, NH 03104 US Other 510(k) Applications for this Company
Contact	Stewart B. Davis 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	11/15/2019
Decision Date	04/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review