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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K874193
Device Name MICROSHEV MODEL 2000
Applicant
MICRO-SHEV LTD.
CO/TERRIS/EDGECOMBE/HECK/WAYNE
1121 12TH STREET, N.W.
WASHINGTON,  DC  20005
Applicant Contact ELLEN K WAYNE
Correspondent
MICRO-SHEV LTD.
CO/TERRIS/EDGECOMBE/HECK/WAYNE
1121 12TH STREET, N.W.
WASHINGTON,  DC  20005
Correspondent Contact ELLEN K WAYNE
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received10/14/1987
Decision Date 03/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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