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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device aspirator, endometrial
Regulation Description Endometrial aspirator.
Product CodeHFF
Regulation Number 884.1060
Device Class 2


Premarket Reviews
ManufacturerDecision
GYNETICS MEDICAL PRODUCTS NV
  SUBSTANTIALLY EQUIVALENT 1
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material separation 4
Sticking 1
Break 1
Entrapment of device or device component 1
Material fragmentation 1
Total Device Problems 8

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