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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K103031
Device Name BMR FACE
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
NFO  
Date Received10/12/2010
Decision Date 11/10/2011
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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