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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K992652
Device Name SD-730 IF-SDS, PERFECT PULSE IF-SDS
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 Number882.5890
Classification Product Code
LIH  
Date Received08/06/1999
Decision Date 02/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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