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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lubricant, patient
Regulation Description Patient lubricant.
Product CodeKMJ
Regulation Number 880.6375
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AVAIL MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOFILM, INC.
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
HYGENIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
NURSE ASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPAN-AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPIRUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SSL
  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 6 1 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Amerx Health Care Corp. II Jul-20-2016
2 Apogee Medical II Feb-03-2011
3 Cardinal Health II Apr-13-2011
4 DeRoyal Processing Center II Apr-18-2011
5 Eli Lilly and Company II May-12-2011
6 H & P Industries, Inc. dba Triad Group II Jan-21-2011
7 Teleflex Medical II Apr-05-2011
8 Westone Laboratories, Inc. II Jul-20-2012

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