Clearance Summary
CONTAIN(TM) LASER PLUME FILTER received FDA 510(k) clearance under submission number K902167, sponsored by Arbor Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1991-01-04.
- Submission: K902167
- Applicant / Sponsor: Arbor Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4220
- Decision date: 1991-01-04
Classification & Regulation
This clearance is catalogued under FDA product code JDY and 21 CFR 888.4220, within the Orthopedic review panel as a Class I device.