FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUJI II
K Number: K980682
·
Decision Apr 3, 1998
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
495
Applicant Total
98
Review Days
39
Basic Information
- Device Name
- FUJI II
- K Number
- K980682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GC AMERICA, INC.
- Date Received
- February 23, 1998
- Decision Date
- April 3, 1998
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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