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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, vibration threshold measurement
510(k) Number K853608
Device Name NEUROMETER
Applicant
NEUROTRON, INC.
6211 FALLS RD.
BALTIMORE,  MD  21209 -2107
Applicant Contact JEFFERSON KATIMS
Correspondent
NEUROTRON, INC.
6211 FALLS RD.
BALTIMORE,  MD  21209 -2107
Correspondent Contact JEFFERSON KATIMS
Regulation Number882.1200
Classification Product Code
LLN  
Date Received08/28/1985
Decision Date 06/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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