Clearance Summary
STOCKINETTE, TUBULAR UNBLEACHED received FDA 510(k) clearance under submission number K790210, sponsored by The Owenby Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1979-02-27.
- Submission: K790210
- Applicant / Sponsor: The Owenby Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5075
- Decision date: 1979-02-27
Classification & Regulation
This clearance is catalogued under FDA product code FQM and 21 CFR 880.5075, within the General Hospital review panel as a Class I device.