Clearance Summary
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER received FDA 510(k) clearance under submission number K030574, sponsored by Glustitch, 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 2003-08-21.
- Submission: K030574
- Applicant / Sponsor: Glustitch, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 2003-08-21
Classification & Regulation
This clearance is catalogued under FDA product code KMF and 21 CFR 880.5090, within the General Hospital review panel as a Class I device.