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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fiber, medical, absorbent
Regulation Description Medical absorbent fiber.
Product CodeFRL
Regulation Number 880.5300
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 2
MILLIKEN & CO.
  SUBSTANTIALLY EQUIVALENT 1
QUICK-MED TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 2
No code available 1
Contamination during use 1
Foreign material 1
Nonstandard device or device component 1
Product quality issue 1
Unknown (for use when the device problem is not known) 1
Failure to obtain samples 1
Total Device Problems 9

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1
Class III 0 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 American Surgical Company II May-26-2016
2 Coloplast Corp Skin Care Div III Sep-04-2009

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