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FDA 510(k) Application Details - K002832
Device Classification Name
Media, Electroconductive
More FDA Info for this Device
510(K) Number
K002832
Device Name
Media, Electroconductive
Applicant
SKYLARK DEVICE & SYSTEMS CO., LTD
34 CHUNG SHAN NORTH RD.,
12TH FL., SEC. 3
TAIPEI TW
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Contact
GEORGE K.C. CHEN
Other 510(k) Applications for this Contact
Regulation Number
882.1275
More FDA Info for this Regulation Number
Classification Product Code
GYB
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More FDA Info for this Product Code
Date Received
09/11/2000
Decision Date
08/06/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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