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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, manual, specialized obstetric-gynecologic
Product CodeKNA
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK UROLOGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
GLENVEIGH SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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