Clearance Summary
MIKRO-AQUAPURATOR received FDA 510(k) clearance under submission number K895756, sponsored by Mikro-Tek Laboratories. 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 1989-12-27.
- Submission: K895756
- Applicant / Sponsor: Mikro-Tek Laboratories
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1989-12-27
Classification & Regulation
This clearance is catalogued under FDA product code GBX and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.