Product code NMA

Device name

Tube, Tracheal, Reprocessed

Medical specialty

Anesthesiology

Device class

2

Regulation number

868.5730

Review panel

AN

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Source

FDA openFDA device classification dataset