QJL — Splint, Intranasal Septal, Cber Led Class I

FDA Device Classification

FDA product code QJL covers "Splint, Intranasal Septal, Cber Led", a Class I medical device regulated under 21 CFR 874.4780. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
QJL
Device Class
Class I
Regulation Number
874.4780
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Definition

Splint, Intranasal Septal, CBER led

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K160101bioinspire technologies, incorporatedSinuBandJuly 27, 2016