Clearance Summary
NEZHAT-DORSEY THERMAL RETENTION SYSTEM received FDA 510(k) clearance under submission number K951300, sponsored by American Hydro-Surgical Instruments, 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 1995-06-20.
- Submission: K951300
- Applicant / Sponsor: American Hydro-Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5950
- Decision date: 1995-06-20
Classification & Regulation
This clearance is catalogued under FDA product code LHC and 21 CFR 890.5950, within the Physical Medicine review panel as a Class I device.