FDA 510(k) Application Details - K231063

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K231063
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	SOMAVAC Medical Solutions, Inc. 3144 Stage Post Rd Unit 101 Bartlett, TN 38133 US Other 510(k) Applications for this Company
Contact	Phil Ryan 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	04/14/2023
Decision Date	05/12/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review