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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 K896408
Device Name QUANTUM
Applicant
Stressmaster Systems, Inc.
1930 Topanga Skyline Dr.
Topanga,  CA  90290
Applicant Contact DANIELLE KENNEDY
Correspondent
Stressmaster Systems, Inc.
1930 Topanga Skyline Dr.
Topanga,  CA  90290
Correspondent Contact DANIELLE KENNEDY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/07/1989
Decision Date 09/20/1990
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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