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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, breast, powered
Regulation Description Powered breast pump.
Product CodeHGX
Regulation Number 884.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
FIRST YEARS
  SUBSTANTIALLY EQUIVALENT 4
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEALTHTEAM
  SUBSTANTIALLY EQUIVALENT 2
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
HYGEIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MED-EL
  SUBSTANTIALLY EQUIVALENT 1
MEDELA
  SUBSTANTIALLY EQUIVALENT 7
PLAYTEX PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCHUCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
UZINMEDICARE CO.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 2 0 0 0
Class III 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medela Inc III Feb-11-2011
2 Medela Inc II Sep-24-2010
3 Medela Inc II Apr-27-2010

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