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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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