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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 K082011
Device Name MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
Applicant
BIO-MEDICAL RESEARCH, LTD.
PARKMORE BUSINESS PARK WEST
GALWAY,  IE
Applicant Contact ANNE-MARIE KEENAN
Correspondent
BIO-MEDICAL RESEARCH, LTD.
PARKMORE BUSINESS PARK WEST
GALWAY,  IE
Correspondent Contact ANNE-MARIE KEENAN
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received07/15/2008
Decision Date 11/28/2008
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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