Product code HDT

Device name

Device, Intrauterine, Contraceptive And Introducer

Medical specialty

Obstetrics/Gynecology

Device class

3

Regulation number

884.5360

Review panel

OB

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86

Source

FDA openFDA device classification dataset