FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL
K Number: K063161
·
Decision Nov 21, 2006
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
17
Review Days
35
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Basic Information
- Device Name
- SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL
- K Number
- K063161
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Leonhard Lang GmbH
- Date Received
- October 17, 2006
- Decision Date
- November 21, 2006
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Leonhard Lang GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K142803 | Skintact, various other tradenames | Dec 2, 2014 | Substantially Equivalent |
| K140500 | SKINTACT | Jul 29, 2014 | Substantially Equivalent |
| K140340 | SKINTACT | May 21, 2014 | Substantially Equivalent |
| K103186 | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES | Feb 8, 2011 | Substantially Equivalent |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | Aug 21, 2009 | Substantially Equivalent |
| K081371 | SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL | Sep 24, 2008 | Substantially Equivalent |
| K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | Feb 1, 2008 | Substantially Equivalent |
| K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES | Nov 16, 2007 | Substantially Equivalent |
| K072233 | SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS | Oct 5, 2007 | Substantially Equivalent |
| K041883 | SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 | Sep 7, 2004 | Substantially Equivalent |