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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device curette, suction, endometrial (and accessories)
Regulation Description Endometrial suction curette and accessories.
Product CodeHHK
Regulation Number 884.1175
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MARINA MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNIMAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device, or device fragments remain in patient 1
Material separation 1
Total Device Problems 2

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