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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, retention type
Regulation Description Gastrointestinal tube and accessories.
Product CodeEZK
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 3
Leak 2
Material separation 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 7

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