510(k) K823865
- Device
- Advance Sys. Emit-cad Lidocaine Control
- Applicant
- SYVA CO.
- 510(k) number
- K823865
- Product code
- LAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-14
- Date received
- 1982-12-23
- Regulation
- 862.3280
- Classification name
- Lidocaine Control Materials
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 1
- 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