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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gastrostomy tube holder
Regulation Description Gastrointestinal tube and accessories.
Definition Intended to support, secure, and hold gastrostomy tubes
Product CodePLI
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
DALE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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