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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 K040311
Device Name SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331
Applicant
SHIAN JIA MEEI ENTERPRISE CO., LTD.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
SHIAN JIA MEEI ENTERPRISE CO., LTD.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/09/2004
Decision Date 10/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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