Clearance Summary
BASIN PACK received FDA 510(k) clearance under submission number K802538, sponsored by Texas Medical Products, 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 1980-10-31.
- Submission: K802538
- Applicant / Sponsor: Texas Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6730
- Decision date: 1980-10-31
Classification & Regulation
This clearance is catalogued under FDA product code FNY and 21 CFR 880.6730, within the General Hospital review panel as a Class I device.