Device type

Drape, Surgical, Exempt

Product code PUI · Class II · 21 CFR 878.4370 · General, Plastic Surgery

This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

FDA classification database