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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 K874085
Device Name REBUILDER(TM)
Applicant
MICROMED, INC.
THE KILN
15 BRICKYARD ROAD
essex junction,  VT  05452
Applicant Contact david b phillips
Correspondent
MICROMED, INC.
THE KILN
15 BRICKYARD ROAD
essex junction,  VT  05452
Correspondent Contact david b phillips
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/07/1987
Decision Date 12/11/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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