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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Media, Electroconductive
510(k) Number K983964
Device Name BATCH #6060 CONDUCTIVE GEL
Applicant
SKYLARK DEVICE CO., LTD.
34 CHUNG SHAN NORTH RD.,
12TH FL., SEC. 3
TAIPEI,  TW
Applicant Contact GEORGE CHEN
Correspondent
SKYLARK DEVICE CO., LTD.
34 CHUNG SHAN NORTH RD.,
12TH FL., SEC. 3
TAIPEI,  TW
Correspondent Contact GEORGE CHEN
Regulation Number882.1275
Classification Product Code
GYB  
Date Received11/06/1998
Decision Date 12/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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