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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 K121483
Device Name REUSABLE CUTANEOUS ELECTRODE
Applicant
AMPCARE, LLC
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON,  TX  75080
Applicant Contact DIANE RUTHERFORD
Correspondent
AMPCARE, LLC
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/18/2012
Decision Date 10/15/2012
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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