FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALEXOTEK LINGUAL TUBES
K Number: K834446
·
Decision Apr 5, 1984
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
7
Applicant Total
4
Review Days
111
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Basic Information
- Device Name
- ALEXOTEK LINGUAL TUBES
- K Number
- K834446
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Alexotek Co.
- Date Received
- December 16, 1983
- Decision Date
- April 5, 1984
- Product Code
- DZD
- 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 |
|---|---|---|---|
| DZD | Tube, Orthodontic | FDA class 1 | Dental |
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