FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHO-LEVEL
K Number: K822305
·
Decision Aug 20, 1982
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
2
Applicant Total
4
Review Days
24
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Basic Information
- Device Name
- ORTHO-LEVEL
- K Number
- K822305
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4600
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Frontier Products
- Date Received
- July 27, 1982
- Decision Date
- August 20, 1982
- Product Code
- HTH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HTH | Protractor | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTH), ordered by most recent decision date.
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FDA 510(k)
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