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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K050123
Device Name P-STIM SYSTEM
Applicant
Neuroscience Therapy Corp.
135 Lake St. S.
Suite 100
Kirkland,  WA  98033
Applicant Contact JAN MCCOMB
Correspondent
Neuroscience Therapy Corp.
135 Lake St. S.
Suite 100
Kirkland,  WA  98033
Correspondent Contact JAN MCCOMB
Classification Product Code
BWK  
Date Received01/19/2005
Decision Date 03/30/2006
Decision Substantially Equivalent (SESE)
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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