Clearance Summary
DRIPTROL received FDA 510(k) clearance under submission number K902808, sponsored by Trans-Pacific Healthcare-USA. 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 1990-10-01.
- Submission: K902808
- Applicant / Sponsor: Trans-Pacific Healthcare-USA
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2420
- Decision date: 1990-10-01
Classification & Regulation
This clearance is catalogued under FDA product code FLN and 21 CFR 880.2420, within the General Hospital review panel as a Class II device.