FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURALASTIC ANATOMICAL MALAR IMPLANTS
K Number: K971479
·
Decision Jul 18, 1997
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
39
Applicant Total
9
Review Days
86
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Basic Information
- Device Name
- DURALASTIC ANATOMICAL MALAR IMPLANTS
- K Number
- K971479
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allied Biomedical Corp.
- Date Received
- April 23, 1997
- Decision Date
- July 18, 1997
- 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 Allied Biomedical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K982051 | KELOCATE SHEETING | Aug 5, 1998 | Substantially Equivalent |
| K971481 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Jul 18, 1997 | Substantially Equivalent |
| K971478 | DURALASTIC ANATOMICAL CHIN IMPLANTS | Jul 18, 1997 | Substantially Equivalent |
| K971480 | DURALASTIC I AND DURALASTIC II | May 28, 1997 | Substantially Equivalent |
| K955368 | DURALASTIC I | Feb 8, 1996 | Substantially Equivalent |
| K955370 | DURALASTIC II | Feb 8, 1996 | Substantially Equivalent |
| K955433 | DURALASTIC SILICONE TUBING | Jan 26, 1996 | Substantially Equivalent |
| K954413 | KELOCOTE | Nov 29, 1995 | Substantially Equivalent |