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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrode, Depth
510(k) Number K802151
Device Name PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC
Applicant
PROGRESS MANKIND TECHNOLOGY
BOX 464
HOPKINS,  MN  55343
Applicant Contact Alfred A Iversen
Correspondent
PROGRESS MANKIND TECHNOLOGY
BOX 464
HOPKINS,  MN  55343
Correspondent Contact Alfred A Iversen
Regulation Number882.1330
Classification Product Code
GZL  
Date Received09/08/1980
Decision Date 11/19/1980
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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