FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
LIGHT COAGULATOR LC 250
K Number: K881334
·
Decision Nov 16, 1989
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
30
Applicant Total
1
Review Days
596
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Basic Information
- Device Name
- LIGHT COAGULATOR LC 250
- K Number
- K881334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Nk-Optik GmbH
- Date Received
- March 30, 1988
- Decision Date
- November 16, 1989
- Product Code
- HAM
- 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 |
|---|---|---|---|
| HAM | Apparatus, Electrosurgical | FDA class 2 | General, Plastic Surgery |
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