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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, Dental
510(k) Number K901902
Device Name ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE
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 Number890.5850
Classification Product Code
NUW  
Date Received04/27/1990
Decision Date 10/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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