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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, intrauterine insemination
Regulation Description Cervical cap.
Product CodeMFD
Regulation Number 884.5250
Device Class 2


Premarket Reviews
ManufacturerDecision
CONCEPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
GENX INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
UNIMAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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