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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K991397
Device Name TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
Applicant
Sein Electronics Co., Ltd.
1540 Barclay Blvd.
Buffalo Grove,  IL  60089
Applicant Contact S.H. HWANG
Correspondent
Sein Electronics Co., Ltd.
1540 Barclay Blvd.
Buffalo Grove,  IL  60089
Correspondent Contact S.H. HWANG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/21/1999
Decision Date 02/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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