OWR — Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery Class II

FDA Device Classification

Classification Details

Product Code
OWR
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

For reinforcement of soft tissue where weakness exists in facial plastic surgery.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201153shanghai suokang medical implants coTisuthes e-PTFE Surgical PatchJune 13, 2023