FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CONMED BEAMER SYSTEM C600
K Number: K081678
·
Decision Jul 29, 2008
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
2
Review Days
42
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Basic Information
- Device Name
- CONMED BEAMER SYSTEM C600
- K Number
- K081678
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kls Martin GmbH + Co. KG
- Date Received
- June 17, 2008
- Decision Date
- July 29, 2008
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
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 Kls Martin GmbH + Co. KG
| K Number | Device Name | ||
|---|---|---|---|
| K183526 | Codman Electrosurgical Generator, Foot Pedal | Apr 11, 2019 | Substantially Equivalent |