Product code OWU

Device name

Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.3300

Review panel

SU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.

Source

FDA openFDA device classification dataset