Clearance Summary
MESULIN INSULIN INFUSION SET received FDA 510(k) clearance under submission number K833398, sponsored by Molnlycke A/S Hospital Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1984-03-06.
- Submission: K833398
- Applicant / Sponsor: Molnlycke A/S Hospital Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1984-03-06
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.