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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 K981976
Device Name ACUTRON MENTOR MODEL 961
Applicant
Microcurrent Research, Inc.
3810 E. Desert Cove Ave.
Phoenix,  AZ  85028
Applicant Contact PAUL DAVIS
Correspondent
Microcurrent Research, Inc.
3810 E. Desert Cove Ave.
Phoenix,  AZ  85028
Correspondent Contact PAUL DAVIS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/01/1998
Decision Date 11/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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