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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device brachial plexus anesthesia kit
Regulation Description Anesthesia conduction 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 CodeOGA
Regulation Number 868.5140
Device Class 2

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