Device |
brachial plexus anesthesia kit |
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 type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. |
Product Code | OGA |
Regulation Number |
868.5140
|
Device Class |
2
|
|
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