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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Encephalogram Telemetry System
510(k) Number K860128
Device Name MODAC-XXXX INTENSIVE MONITORING OF EEG
Applicant
Grass-Telefactor Product Group
Union Hill Bldg., Dehaven St.
W. Conshohocken,  PA  19428
Applicant Contact JOHN CHATTEN
Correspondent
Grass-Telefactor Product Group
Union Hill Bldg., Dehaven St.
W. Conshohocken,  PA  19428
Correspondent Contact JOHN CHATTEN
Regulation Number882.1855
Classification Product Code
GYE  
Date Received01/14/1986
Decision Date 03/27/1986
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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