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510(k) K894911

SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 by Dantec Electronics, Inc. — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1990
Date Received
August 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

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  • K881915 — DANTEC MAGNETIC STIMULATOR (October 17, 1988)
  • K874758 — DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE (April 14, 1988)
  • K874759 — 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE (April 14, 1988)
  • K874735 — DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE (January 22, 1988)
  • K870567 — EVOPORT 300 (October 6, 1987)
  • K872106 — DANTEC COUNTERPOINT (September 10, 1987)
  • K860368 — URDYN 5000 (UROFLOWMETER) (April 23, 1986)
  • K853119 — URODYN 1000 (October 4, 1985)

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