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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device masker, tinnitus
Regulation Description Tinnitus masker.
Product CodeKLW
Regulation Number 874.3400
Device Class 2


Premarket Reviews
ManufacturerDecision
ADM TRONICS UNLTD, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUDIFON GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BELTONE ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
GENERAL HEARING INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GN RESOUND A/S
  SUBSTANTIALLY EQUIVALENT 3
MELMEDTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3
STARKEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 8
TINNITUS CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 2
TINNITUS OTOSOUND PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

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