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510(k) K080914

ULTRASHARP CONCENTRIC NEEDLES by Rochester Electro Medical, Inc. — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2008
Date Received
April 1, 2008
Clearance Type
Abbreviated
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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