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510(k) K990375

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 by Medtronic Functional Diagnostics A/S — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1999
Date Received
February 8, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

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  • K991389 — ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 (July 15, 1999)
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