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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, over-the-counter
510(k) Number K121353
Device Name MINI PATCH
Original Applicant
WELL-LIFE HEALTHCARE LIMITED
1fl, no.16, lane 454
jungjeng rd.
yunghe city, taipei county,  TW ch
Original Contact chin-chin hsieh
Regulation Number882.5890
Classification Product Code
NUH  
Date Received05/04/2012
Decision Date 09/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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