510(k) K110609
- Device
- EPIDUCER LEAD DELIVERY SYSTEM
- Applicant
- ST. JUDE MEDICAL
- 510(k) number
- K110609
- Product code
- LHG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-06-24
- Date received
- 2011-03-03
- Regulation
- 882.5880
- Classification name
- Electrode, Spinal Epidural
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RASHMI MOZA
- Address
- 6901 Preston Rd. Plano TX US 75024 75024
FDA Registration Numbers#
- 1422634
- 1627487
- 1928237
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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