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LZL — Micro-Condom Class III

FDA Device Classification

FDA product code LZL covers "Micro-Condom", a Class III medical device regulated under 21 CFR 884.5320. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code: LZL
Device Class: Class III
Regulation Number: 884.5320
Submission Type
Review Panel: OB
Medical Specialty: Obstetrics/Gynecology
Implant: No

Definition

Call for PMAs to be filed by 9/12/02 per 67 FR 40849 on 6/14/02