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510(k) K111131

TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES by Carefusion 209, Inc. — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2011
Date Received
April 21, 2011
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

Other clearances by Carefusion 209, Inc.

  • K120979 — CAREFUSION NICOLET EDX (April 25, 2012)
  • K112052 — CAREFUSION NICOLET EDX (March 15, 2012)
  • K112034 — TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (August 12, 2011)
  • K103140 — NICOLET WIRELESS EEG (April 8, 2011)

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  • K120342 — EMG RECORDING ELECTRODE ASSEMBLY (June 22, 2012)
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  • K092973 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR N (October 7, 2010)
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