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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope kit
Regulation Description Rigid laryngoscope.
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.
Product CodeOGH
Regulation Number 868.5540
Device Class 1

Device Problems
Failure to conduct 5
Optical issue 4
Inadequate lighting 3
Break 1
Device inoperable 1
Fitting problem 1
Connection issue 1
Device operates differently than expected 1
Total Device Problems 17

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