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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 K120569
Device Name GEMORE TENS SYSTEM
Original Applicant
GEMORE TECHNOLOGY CO., LTD.
11 fl, no. 29-5, sec. 2
chung cheng e. rd.
tan shui, taipei hsien,  TW 251
Original Contact boden s.p. lai
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
NYN  
Date Received02/27/2012
Decision Date 07/20/2012
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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