FDA 510(k) Application Details - K243138

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K243138
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	Geon Corporation No. 12, Gung Ye Road Hsi Hu Chang Hwa Hsien 514 TW Other 510(k) Applications for this Company
Contact	Henry 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	09/30/2024
Decision Date	02/04/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review