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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K083758
Device Name SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
Applicant
The Electrode Store, Inc.
1530 Holcomb St.
Port Townsend,  WA  98368
Applicant Contact CARL YOUNGMANN
Correspondent
The Electrode Store, Inc.
1530 Holcomb St.
Port Townsend,  WA  98368
Correspondent Contact CARL YOUNGMANN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/17/2008
Decision Date 08/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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