Clearance Summary
MONTROSE DRESSING APPLICATORS received FDA 510(k) clearance under submission number K905519, sponsored by Olemunda Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1991-03-06.
- Submission: K905519
- Applicant / Sponsor: Olemunda Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4020
- Decision date: 1991-03-06
Classification & Regulation
This clearance is catalogued under FDA product code NAD and 21 CFR 878.4020, within the General, Plastic Surgery review panel as a Class I device.