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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clamp, umbilical
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeHFW
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 2
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
WELCON, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Malfunction 2
Defective item 1
Device displays error message 1
Close, difficult to 1
Free or unrestricted flow 1
Total Device Problems 6

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

Recalls
Manufacturer Recall Class Date Posted
1 Cypress Medical Products LLC II May-08-2013

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