Product code OGF
- Device name
- Glossopharyngeal Anesthesia Kit
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5120
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
- Source
- FDA openFDA device classification dataset