Product code LZL

Device name

Micro-Condom

Medical specialty

Obstetrics/Gynecology

Device class

3

Regulation number

884.5320

Review panel

OB

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Call for PMAs to be filed by 9/12/02 per 67 FR 40849 on 6/14/02

Source

FDA openFDA device classification dataset