FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
Luvis Chair (LC700C)
K Number: K233921
·
Decision Sep 6, 2024
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
62
Applicant Total
37
Review Days
268
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Basic Information
- Device Name
- Luvis Chair (LC700C)
- K Number
- K233921
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentis Co., Ltd.
- Date Received
- December 13, 2023
- Decision Date
- September 6, 2024
- Product Code
- KLC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| KLC | Chair, Dental, With Operative Unit | FDA class 1 | Dental |
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