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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device monitor, esophageal motility, anorectal motility, and tube
Product CodeKLA
Regulation Number 876.1725
Device Class 2


Premarket Reviews
ManufacturerDecision
THD SPA
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2 2
Break 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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