FDA 510(k) Application Details - K190303

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K190303
Device Name	Insufflator, Laparoscopic
Applicant	ConMed Corporation 525 French Road Utica, NY 13502 US Other 510(k) Applications for this Company
Contact	Lisa Anderson Other 510(k) Applications for this Contact
Regulation Number	884.1730   More FDA Info for this Regulation Number
Classification Product Code	HIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2019
Decision Date	03/28/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review