FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUI ANATOMICAL SILICONE MALAR
K Number: K903329
·
Decision Sep 10, 1990
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
39
Applicant Total
7
Review Days
47
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Basic Information
- Device Name
- CUI ANATOMICAL SILICONE MALAR
- K Number
- K903329
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cui Corp.
- Date Received
- July 25, 1990
- Decision Date
- September 10, 1990
- Product Code
- LZK
- 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 |
|---|---|---|---|
| LZK | Implant, Malar | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZK), ordered by most recent decision date.
AART MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PILLAR MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGIFORM ANATOMICAL MALAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SEARE BIOMEDICAL MALAR IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SILIMED MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K904350 | CUI DORSAL COLUMELLA PROSTHESIS | Nov 26, 1990 | Substantially Equivalent |
| K904349 | CUI CURVILINEAR SILICONE CHIN | Nov 26, 1990 | Substantially Equivalent |
| K903327 | CUI ARTICULATED SILICONE CHIN | Sep 10, 1990 | Substantially Equivalent |
| K903328 | CUI PREMAXILLARY IMPLANT | Sep 10, 1990 | Substantially Equivalent |