FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MITER ENDOSTEAL BLADE IMPLANT
K Number: K791204
·
Decision Sep 28, 1979
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
303
Review Days
92
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Basic Information
- Device Name
- MITER ENDOSTEAL BLADE IMPLANT
- K Number
- K791204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- June 28, 1979
- Decision Date
- September 28, 1979
- Product Code
- NRQ
- 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 |
|---|---|---|---|
| NRQ | Blade-Form Endosseous Dental Implant | FDA class 2 | Dental |
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