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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device high level disinfection reprocessing instrument for ultrasonic transducers, liquid
Definition To provide high level disinfection of ultrasound transducers If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodePSW
Regulation Number 892.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
CS MEDICAL L.L.C.
  SUBSTANTIALLY EQUIVALENT 2
CS MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2

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