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510(k) K063161

SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL by Leonhard Lang GmbH — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2006
Date Received
October 17, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Leonhard Lang GmbH

  • K142803 — Skintact, various other tradenames (December 2, 2014)
  • K140500 — SKINTACT (July 29, 2014)
  • K140340 — SKINTACT (May 21, 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)
  • K041883 — SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 (September 7, 2004)

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