Clearance Summary
CUSTOM DRESSING TRAY-WET TO DRY/MASS. received FDA 510(k) clearance under submission number K802385, sponsored by American Medical Disposable, 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 1980-11-12.
- Submission: K802385
- Applicant / Sponsor: American Medical Disposable, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1980-11-12
Classification & Regulation
This clearance is catalogued under FDA product code FPX and 21 CFR 880.5240, within the General Hospital review panel as a Class I device.