FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VACUDENT LUMIX 65
K Number: K800574
·
Decision May 20, 1980
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
7
Applicant Total
4
Review Days
67
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Basic Information
- Device Name
- VACUDENT LUMIX 65
- K Number
- K800574
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3285
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Vacudent Sales Corp.
- Date Received
- March 14, 1980
- Decision Date
- May 20, 1980
- Product Code
- EHP
- 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 |
|---|---|---|---|
| EHP | Clasp, Preformed | FDA class 1 | Dental |
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