Clearance Summary
HYDROPULSE(GROSSAN);INFLAT TUBE MASS received FDA 510(k) clearance under submission number K834507, sponsored by Amrex-Zetron, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1984-01-17.
- Submission: K834507
- Applicant / Sponsor: Amrex-Zetron, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 1984-01-17
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.