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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, skin potential measurement
510(k) Number K832067
Device Name SHARE INT'L TDM
Applicant
SHARE INT'L
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SHARE INT'L
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1560
Classification Product Code
HCJ  
Date Received06/27/1983
Decision Date 10/27/1983
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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