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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device external urethral occluder, urinary incontinence-control, female
Regulation Description Urological clamp for males.
Definition Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.
Product CodeMNG
Regulation Number 876.5160
Device Class 1


Premarket Reviews
ManufacturerDecision
INSIGHT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
PERSONAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1

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