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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, transcutaneous, for pain relief
510(k) Number K112258
Device Name NEUROTECH PLUS
Applicant
BIO-MEDICAL RESEARCH, LTD.
BMR HOUSE
PARKMORE BUSINESS PARK, WEST
GALWAY,  IE EI
Applicant Contact ANNE-MARIE KEENAN
Correspondent
BIO-MEDICAL RESEARCH, LTD.
BMR HOUSE
PARKMORE BUSINESS PARK, WEST
GALWAY,  IE EI
Correspondent Contact ANNE-MARIE KEENAN
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   NYN  
Date Received08/05/2011
Decision Date 01/09/2012
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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