HPN — Magnet, Permanent Class I

FDA Device Classification

FDA product code HPN covers "Magnet, Permanent", a Class I medical device regulated under 21 CFR 886.4445. Submissions are reviewed by the Ophthalmic panel. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HPN
Device Class
Class I
Regulation Number
886.4445
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K905237king toolEYE SEE INSTRUMENTFebruary 14, 1991
K896473emory university school of medicineH200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SURFebruary 9, 1990
K880855richard jamesPAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAGApril 1, 1988
K860960ameritekRARE EARTH INTRA-OCULAR MAGNETMarch 31, 1986
K831702miami eye technologyRARE-EARTH INTRA-OCULAR MAGNETJune 30, 1983