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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, Electrical, Percutaneous (Pens), For Pain Relief
510(k) Number K022241
Device Name VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX
Applicant
Vertis Neuroscience, Inc.
2101 Fourth Ave. Suite 200
Seattle,  WA  98121 -2329
Applicant Contact LORI GLASTETTER
Correspondent
Vertis Neuroscience, Inc.
2101 Fourth Ave. Suite 200
Seattle,  WA  98121 -2329
Correspondent Contact LORI GLASTETTER
Regulation Number882.5890
Classification Product Code
NHI  
Subsequent Product Code
GXZ  
Date Received07/11/2002
Decision Date 09/11/2002
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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