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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, iontophoresis, specific uses
Regulation Description Iontophoresis device.
Product CodeKTB
Regulation Number 890.5525
Device Class 2


Premarket Reviews
ManufacturerDecision
EMPI
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT WITH DRUG 2
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IOMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 2
  SUBSTANTIALLY EQUIVALENT WITH DRUG 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
WESCOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
WR MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT WITH DRUG 1

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