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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, esophageal
Product CodeESW
Regulation Number 878.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
M.I. TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
M.I. TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
TAEWOONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THORACENT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Aug-31-2010
2 Boston Scientific Corporation II Jun-25-2010
3 Taewoong Medical Co., Ltd. II Feb-14-2020
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