FDA 510(k) Application Details - K213860

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K213860
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Lazurite Holdings LLC 5000 Euclid Avenue, Suite 206 Cleveland, OH 44103 US Other 510(k) Applications for this Company
Contact	Patrick Polito 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	12/10/2021
Decision Date	03/23/2022
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