Clearance Summary
JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE received FDA 510(k) clearance under submission number K884749, 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 1988-12-15.
- Submission: K884749
- Applicant / Sponsor: Johnson & Johnson Patient Care, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6960
- Decision date: 1988-12-15
Classification & Regulation
This clearance is catalogued under FDA product code KYZ and 21 CFR 880.6960, within the General Hospital review panel as a Class I device.