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FDA 510(k) Application Details - K983964
Device Classification Name
Media, Electroconductive
More FDA Info for this Device
510(K) Number
K983964
Device Name
Media, Electroconductive
Applicant
SKYLARK DEVICE CO., LTD.
34 CHUNG SHAN NORTH RD.,
12TH FL., SEC. 3
TAIPEI TW
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Contact
GEORGE CHEN
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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
11/06/1998
Decision Date
12/09/1998
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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