FDA 510(k) Application Details - K180606

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K180606
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	SOMAVAC Medical Solutions, Inc. 20 South Dudley Street, Suite 100 Memphis, TN 38103 US Other 510(k) Applications for this Company
Contact	Esra Roan 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	03/07/2018
Decision Date	05/31/2018
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