FDA 510(k) Application Details - K181667

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K181667
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	Centese, Inc. 3929 Harney St Suite 3008 Omaha, NE 68131 US Other 510(k) Applications for this Company
Contact	Evan Luxon Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	BTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2018
Decision Date	11/29/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review