FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
K Number: K040278
·
Decision Mar 1, 2004
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
225
Applicant Total
28
Review Days
25
Basic Information
- Device Name
- PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
- K Number
- K040278
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NovaBone Products, LLC
- Date Received
- February 5, 2004
- Decision Date
- March 1, 2004
- 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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