FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT
K Number: K942421
·
Decision Aug 8, 1994
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
39
Applicant Total
7
Review Days
80
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Basic Information
- Device Name
- IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT
- K Number
- K942421
- 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
- King & Spalding
- Date Received
- May 20, 1994
- Decision Date
- August 8, 1994
- 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 King & Spalding
| K Number | Device Name | ||
|---|---|---|---|
| K942422 | PANASONIC WRIST BLOOD PRESSURE METER | Feb 15, 1995 | Substantially Equivalent |
| K942423 | NAIS WRIST BLOOD PRESSURE METER | Feb 15, 1995 | Substantially Equivalent |
| K945998 | CHIN IMPLANT STYLE I | Feb 7, 1995 | Substantially Equivalent |
| K944408 | IMPLANTECH MEDICAL GRADE SILICONE SHEETING | Nov 9, 1994 | Substantially Equivalent |
| K942420 | IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT | Aug 8, 1994 | Substantially Equivalent |
| K941972 | HEMO-O-LOK | Jun 29, 1994 | Substantially Equivalent |