FDA 510(k) Application Details - K161002

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K161002
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 US Other 510(k) Applications for this Company
Contact	ERUM B. NASIR 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	04/11/2016
Decision Date	09/28/2016
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