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HKR — Lens, Maddox Class I

FDA Device Classification

FDA product code HKR covers "Lens, Maddox", a Class I medical device regulated under 21 CFR 886.1400. Submissions are reviewed by the Ophthalmic panel.

Classification Details

Product Code: HKR
Device Class: Class I
Regulation Number: 886.1400
Submission Type
Review Panel: OP
Medical Specialty: Ophthalmic
Implant: No