HNX — Depressor, Orbital Class I

FDA Device Classification

FDA product code HNX covers "Depressor, Orbital", a Class I medical device regulated under 21 CFR 886.4350. Submissions are reviewed by the Ophthalmic panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HNX
Device Class
Class I
Regulation Number
886.4350
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K951702future medical systemsFMS HIGH FLOW ARTHRO-SHEATHMay 12, 1995
K951701future medical systemsFMS ARTHRO-CUTTERMay 9, 1995