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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrode, Cutaneous
510(k) Number K875284
Device Name MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact ROBERT C FLINK
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact ROBERT C FLINK
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/24/1987
Decision Date 01/28/1988
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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