Clearance Summary
TETRA NATAL-MAT WATER FLOTATION MAT. received FDA 510(k) clearance under submission number K802833, sponsored by Tetra Group U.S.A., 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 1980-12-10.
- Submission: K802833
- Applicant / Sponsor: Tetra Group U.S.A., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5150
- Decision date: 1980-12-10
Classification & Regulation
This clearance is catalogued under FDA product code IKY and 21 CFR 880.5150, within the General Hospital review panel as a Class I device.