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FDA 510(k) Application Details - K200455
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K200455
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
New Deantronics Taiwan, Ltd.
12F, No. 51, Sec. 4, Chong Yang Road, Tucheng Dist.,
New Taipei City 23675 TW
Other 510(k) Applications for this Company
Contact
Jane Liu
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
GEI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/25/2020
Decision Date
03/31/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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