Tape and Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

What Is This Device?

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

What Is FDA Product Code PYO?

Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use is FDA product code PYO, Class 1, 21 CFR 880.5240.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.