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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, external penile rigidity
Regulation Description External penile rigidity devices.
Definition Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.
Product CodeLKY
Regulation Number 876.5020
Device Class 2


Premarket Reviews
ManufacturerDecision
ENDOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMAGYN MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1
VETCO, INC.
  SUBSTANTIALLY EQUIVALENT 2

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