JZA — Rongeur, Mastoid Class I

FDA Device Classification

FDA product code JZA covers "Rongeur, Mastoid", a Class I medical device regulated under 21 CFR 874.4420. 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
JZA
Device Class
Class I
Regulation Number
874.4420
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K822007kelleherBONE RONGEUNS ENT & RELATED ITEMSAugust 12, 1982