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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, anesthesia, paracervical
Regulation Description Obstetric anesthesia set.
Product CodeHEE
Regulation Number 884.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
AVID MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELLMAN INT'L INC.
  SUBSTANTIALLY EQUIVALENT 1
GYNEX CORP.
  SUBSTANTIALLY EQUIVALENT 1
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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 0
Class III 0 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. III Oct-06-2015

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