FDA 510(k) Application Details - K241852

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K241852
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	AViTA Corporation 9F, No.78, Sec.1, Kwang Fu Road, Sanchong Dist., New Taipei City 24158 TW Other 510(k) Applications for this Company
Contact	Maggie Chao 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	06/27/2024
Decision Date	12/31/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review