FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
K Number: K130235
·
Decision Jan 10, 2014
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
14
Applicant Total
4
Review Days
345
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Basic Information
- Device Name
- SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
- K Number
- K130235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hans Biomed Corp.
- Date Received
- January 30, 2013
- Decision Date
- January 10, 2014
- Product Code
- NUN
- 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 |
|---|---|---|---|
| NUN | Bone Grafting Material, Human Source | FDA class 2 | Dental |
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