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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
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