FDA 510(k) Application Details - K250697

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K250697
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	Shenzhen Kingboom Technology Co., Ltd #201, 2nd fl, No.5, Tongxin Road, Pingdong Community Pingdi Street, Longgang District Shenzhen 518117 CN Other 510(k) Applications for this Company
Contact	Qiang Ma 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	03/07/2025
Decision Date	04/23/2025
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