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FDA 510(k) Application Details - K110289
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K110289
Device Name
Electrode, Cutaneous
Applicant
XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.
NO 9, GAO ZIN 1ST ROAD
HI-TECH DEVELOPMENT ZONE
XI'AN, SHAANXI 710075 CN
Other 510(k) Applications for this Company
Contact
ZHAI YING CHUAN
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2011
Decision Date
08/30/2011
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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