FDA 510(k) Application Details - K232831

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K232831
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	Anoxia Medical Inc. 3475 Investment Boulevard, Suite #9 Hayward, CA 94545 US Other 510(k) Applications for this Company
Contact	Henry Nita 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	09/13/2023
Decision Date	02/22/2024
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