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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pelvic exam kit
Regulation Description Obstetric-gynecologic specialized manual instrument.
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 CodeMLT
Regulation Number 884.4530
Device Class 2


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  SUBSTANTIALLY EQUIVALENT - KIT 1

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