FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUI DORSAL COLUMELLA PROSTHESIS
K Number: K904350
·
Decision Nov 26, 1990
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
41
Applicant Total
7
Review Days
63
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Basic Information
- Device Name
- CUI DORSAL COLUMELLA PROSTHESIS
- K Number
- K904350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cui Corp.
- Date Received
- September 24, 1990
- Decision Date
- November 26, 1990
- Product Code
- FZE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FZE | Prosthesis, Nose, Internal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Cui Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K913140 | SILICONE GEL SHEETING | Sep 30, 1991 | Substantially Equivalent |
| K904348 | CUI FEATHERED SILICONE MALAR | Nov 26, 1990 | Substantially Equivalent |
| K904349 | CUI CURVILINEAR SILICONE CHIN | Nov 26, 1990 | Substantially Equivalent |
| K903329 | CUI ANATOMICAL SILICONE MALAR | Sep 10, 1990 | Substantially Equivalent |
| K903327 | CUI ARTICULATED SILICONE CHIN | Sep 10, 1990 | Substantially Equivalent |
| K903328 | CUI PREMAXILLARY IMPLANT | Sep 10, 1990 | Substantially Equivalent |