HRP — Pen, Marking, Surgical Class I

FDA Device Classification

FDA product code HRP covers "Pen, Marking, Surgical", a Class I medical device regulated under 21 CFR 886.4570. Submissions are reviewed by the Ophthalmic panel.

Classification Details

Product Code
HRP
Device Class
Class I
Regulation Number
886.4570
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No