FDA 510(k) Application Details - K180863

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K180863
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District New Taipei City 24888 TW Other 510(k) Applications for this Company
Contact	Sylvia Liu 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	04/02/2018
Decision Date	12/19/2018
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