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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 K895977
Device Name ACUSOURCE 600 (TENS)
Applicant
Microcurrent Research, Inc.
1440 Whalley Ave.
Suite 224
New Haven,  CT  06515
Applicant Contact PAUL DAVIS
Correspondent
Microcurrent Research, Inc.
1440 Whalley Ave.
Suite 224
New Haven,  CT  06515
Correspondent Contact PAUL DAVIS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/12/1989
Decision Date 01/09/1990
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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