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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mattress and bed deck cover (medical purposes)
Regulation Description Mattress cover for medical purposes.
Definition A mattress and bed deck cover for medical purposes is intended to provide a physical barrier between the patient and the mattress as well as all or parts of the bed deck or frame.
Product CodeQTV
Regulation Number 880.6190
Device Class 1


Premarket Reviews
ManufacturerDecision
TRINITY GUARDION
  SUBSTANTIALLY EQUIVALENT 1

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