FDA 510(k) Application Details - K193315

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K193315
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Xenocor, Inc 630 Komas Dr. Suite 200 Salt Lake City, UT 84108 US Other 510(k) Applications for this Company
Contact	Evan Kelso 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	11/29/2019
Decision Date	01/27/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review