FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SILIMED MALAR IMPLANT
K Number: K981835
·
Decision Jul 9, 1998
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
39
Applicant Total
9
Review Days
44
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Basic Information
- Device Name
- SILIMED MALAR IMPLANT
- K Number
- K981835
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Silimed, LLC
- Date Received
- May 26, 1998
- Decision Date
- July 9, 1998
- 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
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IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
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FDA Class 2
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PILLAR MALAR IMPLANT
FDA 510(k)
FDA Class 2
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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
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Silimed, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K974479 | SILIMED VAGINAL STENT | Aug 5, 1998 | Substantially Equivalent |
| K981852 | SILIMED TISSUE EXPANDER | Aug 5, 1998 | Substantially Equivalent |
| K981851 | SILIMED SILICONE CARVING BLOCK | Jul 9, 1998 | Substantially Equivalent |
| K981850 | SILIMED CHIN IMPLANTS | Jul 9, 1998 | Substantially Equivalent |
| K981833 | SILIMED NASAL L SHAPED IMPLANT | Jun 26, 1998 | Substantially Equivalent |
| K980221 | SILIMED NASAL RETAINER | Apr 2, 1998 | Substantially Equivalent |
| K974482 | SILIMED GLUTEAL IMPLANT | Feb 24, 1998 | Substantially Equivalent |
| K974480 | SILIMED CALF IMPLANT | Feb 24, 1998 | Substantially Equivalent |