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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 K002832
Device Name CONDUCTIVE GEL FOR ULTRASOUND
Applicant
Skylark Device & Systems Co., Ltd.
34 Chung Shan N. Rd.,
12th Floor , Sec. 3
Taipei,  TW
Applicant Contact GEORGE K.C. CHEN
Correspondent
Skylark Device & Systems Co., Ltd.
34 Chung Shan N. Rd.,
12th Floor , Sec. 3
Taipei,  TW
Correspondent Contact GEORGE K.C. CHEN
Regulation Number882.1275
Classification Product Code
GYB  
Date Received09/11/2000
Decision Date 08/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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