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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K844216
Device Name GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR
Applicant
Grass Instrument Co.
101 Old Colony Ave.,
P.O.Box 516
Quincy,  MA  02169
Applicant Contact FRANCIS X RIDGE
Correspondent
Grass Instrument Co.
101 Old Colony Ave.,
P.O.Box 516
Quincy,  MA  02169
Correspondent Contact FRANCIS X RIDGE
Regulation Number882.1550
Classification Product Code
JXE  
Date Received10/31/1984
Decision Date 01/18/1985
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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