Clearance Summary
JOHNSON & JOHNSON TUBE SECUREMENT DEVICE received FDA 510(k) clearance under submission number K895431, sponsored by Johnson & Johnson Patient Care, Inc.. 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 1989-10-13.
- Submission: K895431
- Applicant / Sponsor: Johnson & Johnson Patient Care, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5210
- Decision date: 1989-10-13
Classification & Regulation
This clearance is catalogued under FDA product code KMK and 21 CFR 880.5210, within the General Hospital review panel as a Class I device.