510(k) K832916
- Device
- INIVOX ELECTRODE/CATHETER SYS
- Applicant
- CRITIKON COMPANY,LLC
- 510(k) number
- K832916
- Product code
- LLE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-14
- Date received
- 1983-08-29
- Regulation
- 510(k) Premarket Notification
- Classification name
- Stimulator, Spinal-cord, Implanted For Peripheral Vascular Disease
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Neurology
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LLE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K833430 | BLOOD GAS EXPERSYSTEM 8700 | Medical Intelcom, Inc. | 1984-02-10 |
Legacy Summary#
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FDA Review#
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