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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
510(k) Number K895838
Device Name BRACKMANN EMG MONITORING SYSTEM
Applicant
WR MEDICAL ELECTRONICS CO.
123 NO.2ND.STREET
STILLWATER,  MN  55082
Applicant Contact PATRICK J ANDERSON
Correspondent
WR MEDICAL ELECTRONICS CO.
123 NO.2ND.STREET
STILLWATER,  MN  55082
Correspondent Contact PATRICK J ANDERSON
Regulation Number874.1820
Classification Product Code
ETN  
Date Received10/02/1989
Decision Date 03/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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