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510(k) K955335

DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE by Chalgren Enterprises, Inc. — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1996
Date Received
November 20, 1995
Clearance Type
Traditional
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 Chalgren Enterprises, Inc.

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  • K960591 — RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-X (June 13, 1996)
  • K953361 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K953354 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K953356 — EMG RECORDING RING ELECTRODE (January 22, 1996)
  • K952690 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K952908 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K953887 — RE-USABLE CONCENTRIC NEEDLE (October 31, 1995)
  • K953886 — RE-USABLE MONOPOLAR NEEDLE (October 31, 1995)
  • K953219 — 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN (October 6, 1995)

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