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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cover, mattress (medical purposes)
Regulation Description Mattress cover for medical purposes.
Product CodeFMW
Regulation Number 880.6190
Device Class 1


Premarket Reviews
ManufacturerDecision
PRECISION FABRICS GROUP INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION FABRICS GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material Rupture 3
Adverse Event Without Identified Device or Use Problem 2
Sharp Edges 1
Total Device Problems 6

Recalls
Manufacturer Recall Class Date Posted
1 Primus Medical LLC II Sep-09-2014

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