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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applicator, transurethral, radio frequency, for stress urinary incontinence in women
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility.
Product CodeNVJ
Regulation Number 878.4400
Device Class 2

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