Clearance Summary
DISPENSA-LUBE received FDA 510(k) clearance under submission number K903717, sponsored by Gam-Med Packaging Corp.. 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 1990-09-06.
- Submission: K903717
- Applicant / Sponsor: Gam-Med Packaging Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 1990-09-06
Classification & Regulation
This clearance is catalogued under FDA product code KMJ and 21 CFR 880.6375, within the General Hospital review panel as a Class I device.