KAL — Retractor, Ent Class I

FDA Device Classification

FDA product code KAL covers "Retractor, Ent", a Class I medical device regulated under 21 CFR 874.4420. Submissions are reviewed by the Ear, Nose, Throat panel. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KAL
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
K870758treace medicalSMALL MASTOID RETRACTORMarch 4, 1987
K833604microtek medicalADJUSTABLE FORK RETRACTORJanuary 3, 1984
K772381edward weckRING HANDLE & RETRACTORSJanuary 17, 1978
K772392edward weckALLPORT MASTOID RETRACTORSJanuary 17, 1978
K760851v. mueller o.v. baxter healthcareCONVERSE ALTAR RETRACTORMarch 10, 1977