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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device respirator,surgical
Regulation Description Surgical apparel.
Product CodeMSH
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
HANDAN HANGYONG PROTECTIVE & CLEAN PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1
INOVEL LLC
  SUBSTANTIALLY EQUIVALENT 5
LOUIS M. GERSON CO., INC.
  SUBSTANTIALLY EQUIVALENT 3
MOLDEX/METRIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MOLNLYCKE HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
PRESTIGE AMERITECH
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI DASHENG HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHUENN BAO SHING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Patient-device incompatibility 1
No Known Device Problem 1
Not Applicable 1
Total Device Problems 3

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 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Inovel LLC III Jul-13-2009

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