FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Rainbow LS Pressing
K Number: K151846
·
Decision Jan 14, 2016
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
471
Applicant Total
5
Review Days
191
Basic Information
- Device Name
- Rainbow LS Pressing
- K Number
- K151846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GENOSS
- Date Received
- July 7, 2015
- Decision Date
- January 14, 2016
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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