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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 K091317
Device Name LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
Applicant
BIO-MEDICAL RESEARCH, LTD.
BMR HOUSE
PARKMORE BUSINESS PARK, WEST
GALWAY,  IE
Applicant Contact ANNE-MARIE KEENAN
Correspondent
BIO-MEDICAL RESEARCH, LTD.
BMR HOUSE
PARKMORE BUSINESS PARK, WEST
GALWAY,  IE
Correspondent Contact ANNE-MARIE KEENAN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/04/2009
Decision Date 06/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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