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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device extracorporeal shock wave device for treatment of diabetic foot ulcers
Regulation Description Extracorporeal shock wave device for treatment of chronic wounds.
Definition Treatment of diabetic foot ulcers
Product CodePZL
Regulation Number 878.4685
Device Class 2


Premarket Reviews
ManufacturerDecision
SOFTWAVE./TRT LLC
  SUBSTANTIALLY EQUIVALENT 1
SOFTWAVE/TRT LLC
  SUBSTANTIALLY EQUIVALENT 1
STORZ MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
TISSUE REGENERATION TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

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