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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device masker, tinnitus
Regulation Description Tinnitus masker.
Product CodeKLW
Regulation Number 874.3400
Device Class 2


Premarket Reviews
ManufacturerDecision
AMPLISOUND HEARING PRODUCTS & SERVICES
  SUBSTANTIALLY EQUIVALENT 1
AUDIOFON USA INC.
  SUBSTANTIALLY EQUIVALENT 1
GN HEARING A/S
  SUBSTANTIALLY EQUIVALENT 2
GN RESOUND A/S
  SUBSTANTIALLY EQUIVALENT 1
GN RESOUND A/S (CORPORATE HEADQUARTERS)
  SUBSTANTIALLY EQUIVALENT 1
HANSATON AKUSTIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU BETTERLIFE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KW EAR LAB, INC
  SUBSTANTIALLY EQUIVALENT 1
NEUROTHERAPIES RESET GMBH
  SUBSTANTIALLY EQUIVALENT 1
OTICON A/S
  SUBSTANTIALLY EQUIVALENT 1
OTOHARMONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
SOUND OPTIONS TINNITUS TREATMENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
SOUNDCURE, INC.
  SUBSTANTIALLY EQUIVALENT 1


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