Clearance Summary
STERILE TUBULAR UNBLEACHED STOCKINETTE received FDA 510(k) clearance under submission number K760750, sponsored by Dennison Manufacturing Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1976-10-08.
- Submission: K760750
- Applicant / Sponsor: Dennison Manufacturing Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1290
- Decision date: 1976-10-08
Classification & Regulation
This clearance is catalogued under FDA product code JLG and 21 CFR 862.1290, within the Clinical Chemistry review panel as a Class I device.