Clearance Summary
PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM received FDA 510(k) clearance under submission number K884357, sponsored by Precision Dynamics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1988-11-01.
- Submission: K884357
- Applicant / Sponsor: Precision Dynamics Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3490
- Decision date: 1988-11-01
Classification & Regulation
This clearance is catalogued under FDA product code KOT and 21 CFR 872.3490, within the Dental review panel as a Class I device.