Clearance Summary
TECNOL NASO-GASTRIC TUBE HOLDER received FDA 510(k) clearance under submission number K891187, sponsored by Tecnol New Jersey Wound Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1989-05-30.
- Submission: K891187
- Applicant / Sponsor: Tecnol New Jersey Wound Care, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1989-05-30
Classification & Regulation
This clearance is catalogued under FDA product code BSS and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.