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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device media, electroconductive
Regulation Description Electroconductive media.
Product CodeGYB
Regulation Number 882.1275
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
D.O. WEAVER
  SUBSTANTIALLY EQUIVALENT 3
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 2
SUZUKEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Use of Device Issue 2
Contamination during use 1
Total Device Problems 3

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