PUI · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4370
Classification
FDA Product Code
PUI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4370
Review panel
HO
Medical specialty
General, Plastic Surgery
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.