FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
FORTOSS VITAL
K Number: K082383
·
Decision Sep 5, 2008
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
225
Applicant Total
23
Review Days
17
Basic Information
- Device Name
- FORTOSS VITAL
- K Number
- K082383
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOCOMPOSITES LTD.
- Date Received
- August 19, 2008
- Decision Date
- September 5, 2008
- Product Code
- LYC
- 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
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