FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUXENE VINYL-JECT 3600-80
K Number: K834046
·
Decision Feb 3, 1984
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
373
Review Days
72
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Basic Information
- Device Name
- LUXENE VINYL-JECT 3600-80
- K Number
- K834046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Howmedica Corp.
- Date Received
- November 23, 1983
- Decision Date
- February 3, 1984
- Product Code
- EBF
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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| K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
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| K982958 | ZETA MULTIZONE LOCKING NAIL SYSTEM | Nov 20, 1998 | Substantially Equivalent |
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