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510(k) K140340

SKINTACT by Leonhard Lang GmbH — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2014
Date Received
February 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Leonhard Lang GmbH

  • K142803 — Skintact, various other tradenames (December 2, 2014)
  • K140500 — SKINTACT (July 29, 2014)
  • K103186 — SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES (February 8, 2011)
  • K092291 — SKINTACT AND VARIOUS OTHER TRADENAMES (August 21, 2009)
  • K081371 — SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL (September 24, 2008)
  • K080106 — SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE (February 1, 2008)
  • K073104 — SKINTACT AND VARIOUS OTHER TRADENAMES (November 16, 2007)
  • K072233 — SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMP (October 5, 2007)
  • K063161 — SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL (November 21, 2006)
  • K041883 — SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 (September 7, 2004)

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