FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI LEAD TRIAL CABLE
K Number: K130545
·
Decision Jun 18, 2013
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
138
Applicant Total
105
Review Days
109
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Basic Information
- Device Name
- MULTI LEAD TRIAL CABLE
- K Number
- K130545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- St Jude Medical
- Date Received
- March 1, 2013
- Decision Date
- June 18, 2013
- 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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