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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K034005
Device Name SDS-4I
Applicant
Skylark Device & Systems Co., Ltd.
4f, 34, Sec. 3,
Chung Shan N. Rd.
Taipei,  TW 104
Applicant Contact GEORGE CHIANG
Correspondent
Skylark Device & Systems Co., Ltd.
4f, 34, Sec. 3,
Chung Shan N. Rd.
Taipei,  TW 104
Correspondent Contact GEORGE CHIANG
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
LIH  
Date Received12/24/2003
Decision Date 11/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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