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FDA 510(k) Application Details - K212787
Device Classification Name
Media, Electroconductive
More FDA Info for this Device
510(K) Number
K212787
Device Name
Media, Electroconductive
Applicant
Wuhan Greentek Pty Ltd.
Room 03-2, Floor 3, Dingye Building, Phase III,
International Enterprise Center, Special No. 1, Guanggu Ave
Wuhan 430074 CN
Other 510(k) Applications for this Company
Contact
Yarong Liu
Other 510(k) Applications for this Contact
Regulation Number
882.1275
More FDA Info for this Regulation Number
Classification Product Code
GYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/01/2021
Decision Date
11/08/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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