FDA 510(k) Application Details - K122619

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K122619
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	APPLIED MEDICAL 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 US Other 510(k) Applications for this Company
Contact	JESSICA CHO 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	08/28/2012
Decision Date	10/02/2012
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