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FBR — Urethrometer Class I

FDA Device Classification

FDA product code FBR covers "Urethrometer", a Class I medical device regulated under 21 CFR 876.5520. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code: FBR
Device Class: Class I
Regulation Number: 876.5520
Submission Type
Review Panel: GU
Medical Specialty: Gastroenterology, Urology
Implant: No