Clearance Summary
TRAUMA SLEEVE received FDA 510(k) clearance under submission number K901509, sponsored by Haz-Med, 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 1990-09-12.
- Submission: K901509
- Applicant / Sponsor: Haz-Med, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6060
- Decision date: 1990-09-12
Classification & Regulation
This clearance is catalogued under FDA product code KME and 21 CFR 880.6060, within the General Hospital review panel as a Class I device.