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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K885120
Device Name ESI MODEL MS-103
Applicant
ELECTRICAL SYSTEMS DIV.
8918 TESORO DR.
SUITE 120
SAN ANTONIO,  TX  78217
Applicant Contact PATRICK T THAYER
Correspondent
ELECTRICAL SYSTEMS DIV.
8918 TESORO DR.
SUITE 120
SAN ANTONIO,  TX  78217
Correspondent Contact PATRICK T THAYER
Regulation Number882.4800
Classification Product Code
GZT  
Date Received12/12/1988
Decision Date 01/19/1990
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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