FDA 510(k) Application Details - K241202

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K241202
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	Hetaida Technology Co., Ltd. Rm 801, 802, 803, 804, 901, 2# Bldg Scientific Research Ctr Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town Dongguan 523423 CN Other 510(k) Applications for this Company
Contact	Tom Chen 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	04/30/2024
Decision Date	07/01/2024
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