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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
Definition Treatment of diabetic foot ulcers
Product CodePZL
Regulation Number 878.4685
Device Class 2


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

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