Clearance Summary
BURNS CASUALTY SHEET LIMB WRAP received FDA 510(k) clearance under submission number K900443, sponsored by Pilgrim Medical Services. 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 1990-07-03.
- Submission: K900443
- Applicant / Sponsor: Pilgrim Medical Services
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5180
- Decision date: 1990-07-03
Classification & Regulation
This clearance is catalogued under FDA product code FPY and 21 CFR 880.5180, within the General Hospital review panel as a Class I device.