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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 K820031
Device Name CADWELL 5200
Applicant
CADWELL LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CADWELL LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1550
Classification Product Code
JXE  
Date Received01/06/1982
Decision Date 02/04/1982
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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