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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device perineometer
Regulation Description Perineometer.
Product CodeHIR
Regulation Number 884.1425
Device Class 2


Premarket Reviews
ManufacturerDecision
APIMEDS, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EMPI
  SUBSTANTIALLY EQUIVALENT 2
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 4
REGULATORY INSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 1
THOUGHT TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 3

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