FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BURNETT TMJ APPLIANCE
K Number: K870243
·
Decision Feb 24, 1987
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
9
Applicant Total
105
Review Days
34
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Basic Information
- Device Name
- BURNETT TMJ APPLIANCE
- K Number
- K870243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1830
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Medrad, Inc.
- Date Received
- January 21, 1987
- Decision Date
- February 24, 1987
- Product Code
- EAG
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EAG | Cephalometer | FDA class 2 | Dental |
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