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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dilator, cervical, hygroscopic-laminaria
Regulation Description Hygroscopic Laminaria cervical dilator.
Product CodeHDY
Regulation Number 884.4260
Device Class 2


Premarket Reviews
ManufacturerDecision
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDGYN
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 5
Balloon rupture 2
Break 2
Material fragmentation 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Unable to confirm conditions of use 1
Material integrity issue 1
No code available 1
Total Device Problems 15

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