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510(k) K931966

DANTEC DISPOSABLE CONCENTRIC NEEDLE by Dantec Medical, Inc. — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1994
Date Received
April 21, 1993
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 Dantec Medical, Inc.

  • K960503 — DANTEC DUET (September 16, 1996)
  • K950314 — DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) (March 25, 1996)
  • K953999 — DANTEC DA CAPO (November 21, 1995)
  • K926363 — MULTI-DOP S (June 19, 1995)
  • K931801 — MULTI-DOP X (June 14, 1995)
  • K930458 — MULTI-DOP L (February 3, 1995)
  • K932059 — NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE (October 4, 1994)
  • K934580 — DANTEC 13R45 BAR ELECTRODE (September 26, 1994)
  • K931923 — DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) (November 9, 1993)
  • K926516 — DANTEC MAGNETIC STIMULATOR MAGPRO (August 31, 1993)

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