Clearance Summary
CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 received FDA 510(k) clearance under submission number K862509, sponsored by Lifestream Int'L, 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 1986-07-23.
- Submission: K862509
- Applicant / Sponsor: Lifestream Int'L, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4220
- Decision date: 1986-07-23
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.