FDA 510(k) Application Details - K173389

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K173389
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	Rex Medical, L.P. 555 E. North Ln. Suite 5035 Conshohocken, PA 19428 US Other 510(k) Applications for this Company
Contact	Erich Bressler 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	10/30/2017
Decision Date	01/30/2018
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