FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC MODEL 7499 EXTENSION
K Number: K000445
·
Decision Apr 28, 2000
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
138
Applicant Total
468
Review Days
78
Basic Information
- Device Name
- MEDTRONIC MODEL 7499 EXTENSION
- K Number
- K000445
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDTRONIC VASCULAR
- Date Received
- February 10, 2000
- Decision Date
- April 28, 2000
- Product Code
- GZB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | FDA class 2 | Neurology |
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