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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 K112312
Device Name THERATRODE
Applicant
PHOENIX MEDICAL DEVICES, LLP
2458 ALTON PARKWAY
IRVINE,  CA  92606
Applicant Contact JIM KLETT
Correspondent
PHOENIX MEDICAL DEVICES, LLP
2458 ALTON PARKWAY
IRVINE,  CA  92606
Correspondent Contact JIM KLETT
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/11/2011
Decision Date 01/25/2012
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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