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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 K882980
Device Name REBUILDER BUCKET SYSTEM
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 Received07/15/1988
Decision Date 04/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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