Clearance Summary
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 received FDA 510(k) clearance under submission number K021368, sponsored by Medela AG. 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 2002-05-15.
- Submission: K021368
- Applicant / Sponsor: Medela AG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2002-05-15
Classification & Regulation
This clearance is catalogued under FDA product code BTA and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.