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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 K993823
Device Name MED-4000
Applicant
Micro Current Technology, Inc.
4822 California Ave., SW,
Suite 201
Seattle,  WA  98116
Applicant Contact JAMES Y SUZUKI
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact ROBERT M BOONSTRA
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/12/1999
Decision Date 11/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized
No
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