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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone marrow collection/transfusion 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 CodeLWE
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1

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