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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tape and bandage, adhesive, adjustable closing mechanism, otc use
Regulation Description Medical adhesive tape and adhesive bandage.
Definition A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin
Product CodePYO
Regulation Number 880.5240
Device Class 1


Premarket Reviews
ManufacturerDecision
ZIPLINE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

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