FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GC Fuji Triage EP
K Number: K193484
·
Decision Jul 2, 2020
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
127
Review Days
198
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Basic Information
- Device Name
- GC Fuji Triage EP
- K Number
- K193484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GC America, Inc.
- Date Received
- December 17, 2019
- Decision Date
- July 2, 2020
- 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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