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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 AVENUE,SUITE 200
SEATTLE,  WA  98121 -2329
Applicant Contact LORI GLASTETTER
Correspondent
VERTIS NEUROSCIENCE, INC.
2101 FOURTH AVENUE,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
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